[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-ODA":3},{"classification":4,"mappedDevices":70,"similarCandidates":71,"relatedClassifications":152,"syncDates":574,"translation":581,"marketSummary":588,"recalls":605,"k510s":607,"pmas":676},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":64,"updated_at":65,"recall_count":66,"latest_recall_date":67,"k510_count":68,"pma_count":66,"event_count":69},202,"ODA","Endoscopic Central Control Unit","2","876.1500","GU","Gastroenterology, Urology","1","To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":61,"device_class":8,"implant_flag":62,"product_code":6,"review_panel":10,"gmp_exempt_flag":62,"third_party_flag":62,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":61,"life_sustain_support_flag":62,"medical_specialty_description":11,"summary_malfunction_reporting":63},{"k_number":17,"fei_number":36,"registration_number":54},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35],"K192876","K041912","K083598","K102763","K080410","K020255","K994231","K070827","K981993","K153205","K221929","K151282","K203566","K232406","K051613","K100345","K111165","K022270",[37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53],"3038718579","3002808148","3007475226","3003604053","3013319212","3002808001","1643264","2020550","3007336750","3010707607","1000314502","3002807795","3014342096","3002808268","3002808273","3011050570","3002999813",[37,38,55,56,40,57,58,41,59,43,44,45,46,47,49,60,52],"3010202439","9611102","9615050","9610617","8010047","9614434","","N","Eligible","2026-08-18T05:52:47.660896+00:00","2026-08-24T02:00:49.029844+00:00",0,null,18,27,[],[72,81,89,97,105,113,120,128,136,144],{"medical_device_id":73,"generic_name":74,"class_classification":75,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":80},1779,"内視鏡用電気手術器","Ⅱ","33602000",0.418605,0.200893,0.741336,0.0325225,{"medical_device_id":82,"generic_name":83,"class_classification":84,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":80},3436,"内視鏡用周辺機器コントローラ","Ⅰ","70160000",0.339623,0.251429,0.760186,{"medical_device_id":90,"generic_name":91,"class_classification":92,"jmdn_code":93,"name_similarity":86,"definition_similarity":94,"vector_similarity":95,"score":96},941,"非目視下非鏡視下処置用電気手術器","Ⅲ","70648000",0.174757,0.670305,0.028373,{"medical_device_id":98,"generic_name":99,"class_classification":75,"jmdn_code":100,"name_similarity":101,"definition_similarity":102,"vector_similarity":103,"score":104},1791,"内視鏡用ワーキングエレメント","37085000",0.25,0.187773,0.697145,0.0270563,{"medical_device_id":106,"generic_name":107,"class_classification":75,"jmdn_code":108,"name_similarity":109,"definition_similarity":110,"vector_similarity":111,"score":112},1643,"内視鏡用テレスコープ","37084000",0.289474,0.150769,0.674221,0.026905,{"medical_device_id":114,"generic_name":115,"class_classification":92,"jmdn_code":116,"name_similarity":101,"definition_similarity":117,"vector_similarity":118,"score":119},718,"人工心肺用ガスコントロールユニット","31714000",0.150215,0.692424,0.0261613,{"medical_device_id":121,"generic_name":122,"class_classification":92,"jmdn_code":123,"name_similarity":124,"definition_similarity":125,"vector_similarity":126,"score":127},1108,"中心静脈留置型経皮的体温調節装置コントロールユニット","44709003",0.253333,0.172414,0.68253,0.0259371,{"medical_device_id":129,"generic_name":130,"class_classification":84,"jmdn_code":131,"name_similarity":132,"definition_similarity":133,"vector_similarity":134,"score":135},3589,"低温温度制御装置","16538000",0.28,0.183824,0.664026,0.0253265,{"medical_device_id":137,"generic_name":138,"class_classification":75,"jmdn_code":139,"name_similarity":140,"definition_similarity":141,"vector_similarity":142,"score":143},2556,"トレパンシステムコントロールユニット","43928000",0.282609,0.184549,0.661374,0.025,{"medical_device_id":145,"generic_name":146,"class_classification":75,"jmdn_code":147,"name_similarity":148,"definition_similarity":149,"vector_similarity":150,"score":151},1781,"内視鏡用灌流・吸引装置","36023000",0.26,0.189076,0.661509,0.0234311,[153,157,161,165,169,173,177,181,185,189,193,197,201,205,209,213,217,221,224,228,231,235,239,243,247,250,253,257,261,265,268,272,276,280,283,286,290,293,296,300,304,308,312,315,319,322,325,329,332,336,339,342,345,348,352,356,360,363,366,370,373,376,380,383,386,389,392,395,399,402,405,408,411,414,417,420,424,427,430,433,436,439,442,445,448,451,454,457,460,463,466,470,473,476,479,482,485,488,491,494,497,499,502,505,508,511,514,517,520,523,526,529,532,535,538,541,544,547,550,553,556,559,562,565,568,571],{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"GCJ","Laparoscope, General & Plastic Surgery",1426,{"product_code":158,"device_name":159,"device_class":8,"k510_count":160},"NAY","System, Surgical, Computer Controlled Instrument",165,{"product_code":162,"device_name":163,"device_class":8,"k510_count":164},"FGB","Ureteroscope And Accessories, Flexible\u002FRigid",115,{"product_code":166,"device_name":167,"device_class":8,"k510_count":168},"FDF","Colonoscope And Accessories, Flexible\u002FRigid",113,{"product_code":170,"device_name":171,"device_class":8,"k510_count":172},"FED","Endoscopic Access Overtube, Gastroenterology-Urology",102,{"product_code":174,"device_name":175,"device_class":8,"k510_count":176},"FET","Endoscopic Video Imaging System\u002FComponent, Gastroenterology-Urology",100,{"product_code":178,"device_name":179,"device_class":8,"k510_count":180},"OCX","Endoscopic Irrigation\u002FSuction System",93,{"product_code":182,"device_name":183,"device_class":8,"k510_count":184},"FAJ","Cystoscope And Accessories, Flexible\u002FRigid",92,{"product_code":186,"device_name":187,"device_class":8,"k510_count":188},"FBK","Endoscopic Injection Needle, Gastroenterology-Urology",89,{"product_code":190,"device_name":191,"device_class":8,"k510_count":192},"FDS","Gastroscope And Accessories, Flexible\u002FRigid",76,{"product_code":194,"device_name":195,"device_class":8,"k510_count":196},"OCZ","Endoscopic Grasping\u002FCutting Instrument, Non-Powered",74,{"product_code":198,"device_name":199,"device_class":8,"k510_count":200},"ODC","Endoscope Channel Accessory",72,{"product_code":202,"device_name":203,"device_class":8,"k510_count":204},"OCW","Endoscopic Tissue Approximation Device",70,{"product_code":206,"device_name":207,"device_class":8,"k510_count":208},"OWN","Confocal Optical Imaging",62,{"product_code":210,"device_name":211,"device_class":8,"k510_count":212},"FEB","Accessories, Cleaning, For Endoscope",57,{"product_code":214,"device_name":215,"device_class":8,"k510_count":216},"GCT","Light Source, Endoscope, Xenon Arc",47,{"product_code":218,"device_name":219,"device_class":8,"k510_count":220},"FDX","Endoscopic Cytology Brush",44,{"product_code":222,"device_name":223,"device_class":8,"k510_count":220},"ODG","Endoscopic Ultrasound System, Gastroenterology-Urology",{"product_code":225,"device_name":226,"device_class":8,"k510_count":227},"FBN","Choledochoscope And Accessories, Flexible\u002FRigid",43,{"product_code":229,"device_name":230,"device_class":8,"k510_count":227},"OCY","Endoscopic Guidewire, Gastroenterology-Urology",{"product_code":232,"device_name":233,"device_class":8,"k510_count":234},"LYK","Angioscope",41,{"product_code":236,"device_name":237,"device_class":8,"k510_count":238},"MPA","Endoilluminator",40,{"product_code":240,"device_name":241,"device_class":8,"k510_count":242},"FDT","Duodenoscope And Accessories, Flexible\u002FRigid",35,{"product_code":244,"device_name":245,"device_class":8,"k510_count":246},"FCW","Light Source, Fiberoptic, Routine",31,{"product_code":248,"device_name":249,"device_class":8,"k510_count":69},"FER","Anoscope And Accessories",{"product_code":251,"device_name":252,"device_class":8,"k510_count":69},"OCT","Anti Fog Solution And Accessories, Endoscopy",{"product_code":254,"device_name":255,"device_class":8,"k510_count":256},"FFS","Image, Illumination, Fiberoptic, For Endoscope ",26,{"product_code":258,"device_name":259,"device_class":8,"k510_count":260},"FCX","Insufflator, Automatic Carbon-Dioxide For Endoscope",25,{"product_code":262,"device_name":263,"device_class":8,"k510_count":264},"FAM","Sigmoidoscope And Accessories, Flexible\u002FRigid",24,{"product_code":266,"device_name":267,"device_class":8,"k510_count":264},"FJL","Resectoscope",{"product_code":269,"device_name":270,"device_class":8,"k510_count":271},"NLM","Laparoscope, General & Plastic Surgery, Reprocessed",23,{"product_code":273,"device_name":274,"device_class":8,"k510_count":275},"FEQ","Pump, Air, Non-Manual, For Endoscope",21,{"product_code":277,"device_name":278,"device_class":12,"k510_count":279},"FCO","Box, Battery, Rechargeable",20,{"product_code":281,"device_name":282,"device_class":8,"k510_count":279},"FDA","Enteroscope And Accessories",{"product_code":284,"device_name":285,"device_class":8,"k510_count":279},"ODE","Endoscopic Suture\u002FPlication System, Gastroesophageal Reflux Disease (Gerd)",{"product_code":287,"device_name":288,"device_class":8,"k510_count":289},"FBO","Cystourethroscope",19,{"product_code":291,"device_name":292,"device_class":8,"k510_count":68},"GCM","Endoscope, Rigid",{"product_code":294,"device_name":295,"device_class":8,"k510_count":68},"ODD","Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula",{"product_code":297,"device_name":298,"device_class":8,"k510_count":299},"FHO","Pneumoperitoneum Needle",15,{"product_code":301,"device_name":302,"device_class":8,"k510_count":303},"GCI","Laryngoscope, Endoscope",14,{"product_code":305,"device_name":306,"device_class":8,"k510_count":307},"GCP","Endoscope, Ac-Powered And Accessories",13,{"product_code":309,"device_name":310,"device_class":8,"k510_count":311},"NVE","Washer, Cleaner, Automated, Endoscope",12,{"product_code":313,"device_name":314,"device_class":8,"k510_count":311},"ODF","Mini Endoscope, Gastroenterology-Urology",{"product_code":316,"device_name":317,"device_class":8,"k510_count":318},"FDC","Resectoscope, Working Element",11,{"product_code":320,"device_name":321,"device_class":8,"k510_count":318},"NZA","Accessories, Germicide, Cleaning, For Endoscopes",{"product_code":323,"device_name":324,"device_class":8,"k510_count":318},"OTJ","Laparoscopic Single Port Access Device",{"product_code":326,"device_name":327,"device_class":8,"k510_count":328},"FGA","Kit, Nephroscope",10,{"product_code":330,"device_name":331,"device_class":8,"k510_count":328},"OCV","Endoscope Holder",{"product_code":333,"device_name":334,"device_class":8,"k510_count":335},"GCS","Endoscope, Battery-Powered And Accessories",9,{"product_code":337,"device_name":338,"device_class":8,"k510_count":335},"NTN","Led Light Source",{"product_code":340,"device_name":341,"device_class":8,"k510_count":335},"NWB","Endoscope, Accessories, Narrow Band Spectrum",{"product_code":343,"device_name":344,"device_class":8,"k510_count":335},"PEA","Endoscope, Accessories, Image Post-Processing For Color Enhancement",{"product_code":346,"device_name":347,"device_class":8,"k510_count":335},"PLL","Submucosal Injection Agent",{"product_code":349,"device_name":350,"device_class":8,"k510_count":351},"QSM","System, Surgical, Computer Controlled Instrument, Remanufactured",8,{"product_code":353,"device_name":354,"device_class":8,"k510_count":355},"GDB","Endoscope, Fiber Optic",7,{"product_code":357,"device_name":358,"device_class":8,"k510_count":359},"FHX","Jelly, Lubricating, For Transurethral Surgical Instrument",6,{"product_code":361,"device_name":362,"device_class":12,"k510_count":359},"MNK","Endoscopic Bite Block",{"product_code":364,"device_name":365,"device_class":8,"k510_count":359},"OCU","Endoscopic Storage Cover",{"product_code":367,"device_name":368,"device_class":8,"k510_count":369},"FBP","Telescope, Rigid, Endoscopic",5,{"product_code":371,"device_name":372,"device_class":8,"k510_count":369},"GCQ","Endoscope, Flexible",{"product_code":374,"device_name":375,"device_class":8,"k510_count":369},"ODB","Endoscopic Contamination Prevention Sheath",{"product_code":377,"device_name":378,"device_class":8,"k510_count":379},"FDE","Laparoscopy Kit",4,{"product_code":381,"device_name":382,"device_class":12,"k510_count":379},"FEM","Accessories, Photographic, For Endoscope (Exclude Light Sources)",{"product_code":384,"device_name":385,"device_class":8,"k510_count":379},"FGS","Carrier, Sponge, Endoscopic",{"product_code":387,"device_name":388,"device_class":8,"k510_count":379},"GCL","Esophagoscope, General & Plastic Surgery",{"product_code":390,"device_name":391,"device_class":12,"k510_count":379},"MNL","Accessories, Cleaning Brushes, For Endoscope",{"product_code":393,"device_name":394,"device_class":8,"k510_count":379},"QZB","Software Controlled Endoscope And Instrument Holder",{"product_code":396,"device_name":397,"device_class":8,"k510_count":398},"FCC","Endoscopic Magnetic Retriever",3,{"product_code":400,"device_name":401,"device_class":8,"k510_count":398},"FCR","Light Source, Photographic, Fiberoptic",{"product_code":403,"device_name":404,"device_class":12,"k510_count":398},"FCY","Bulb, Inflation, For Endoscope",{"product_code":406,"device_name":407,"device_class":8,"k510_count":398},"FEC","Obturator, For Endoscope",{"product_code":409,"device_name":410,"device_class":8,"k510_count":398},"FFZ","Cord, Electric, For Endoscope",{"product_code":412,"device_name":413,"device_class":8,"k510_count":398},"FGC","Urethroscope",{"product_code":415,"device_name":416,"device_class":8,"k510_count":398},"GCO","Endoscope, Mirror",{"product_code":418,"device_name":419,"device_class":8,"k510_count":398},"NWU","Endoscope Introducer Kit",{"product_code":421,"device_name":422,"device_class":8,"k510_count":423},"FAK","Panendoscope (Gastroduodenoscope)",2,{"product_code":425,"device_name":426,"device_class":8,"k510_count":423},"FAN","Sigmoidoscope, Rigid, Electrical",{"product_code":428,"device_name":429,"device_class":12,"k510_count":423},"FCP","Box, Battery, Pocket",{"product_code":431,"device_name":432,"device_class":12,"k510_count":423},"FDZ","Attachment, Eyepiece, For Insertion Of Prescription Lens",{"product_code":434,"device_name":435,"device_class":12,"k510_count":423},"FEA","Attachment, Teaching, For Endoscope",{"product_code":437,"device_name":438,"device_class":12,"k510_count":423},"FEI","Instrument, Special Lens, For Endoscope",{"product_code":440,"device_name":441,"device_class":12,"k510_count":423},"FFY","Adaptor, Bulbs, Miscellaneous, For Endoscope",{"product_code":443,"device_name":444,"device_class":8,"k510_count":423},"FHP","Needle, Pneumoperitoneum, Simple",{"product_code":446,"device_name":447,"device_class":8,"k510_count":423},"FTI","Lamp, Endoscope, Incandescent",{"product_code":449,"device_name":450,"device_class":8,"k510_count":423},"GCF","Proctoscope",{"product_code":452,"device_name":453,"device_class":8,"k510_count":423},"KGD","Scissors For Cystoscope",{"product_code":455,"device_name":456,"device_class":8,"k510_count":423},"NBG","Marker, Colon",{"product_code":458,"device_name":459,"device_class":8,"k510_count":423},"NEQ","Device, Telemedicine, Robotic",{"product_code":461,"device_name":462,"device_class":8,"k510_count":423},"PCV","Endoscopic Leak Tester",{"product_code":464,"device_name":465,"device_class":8,"k510_count":423},"SFE","Endoscopic Video Imaging System \u002F Software Component For Real Time Video Augmentation",{"product_code":467,"device_name":468,"device_class":8,"k510_count":469},"FAL","Panendoscope (Urethroscope)",1,{"product_code":471,"device_name":472,"device_class":8,"k510_count":469},"FCQ","Light Source, Incandescent, Diagnostic",{"product_code":474,"device_name":475,"device_class":8,"k510_count":469},"FDP","Apparatus, Pneumoperitoneum, Automatic",{"product_code":477,"device_name":478,"device_class":12,"k510_count":469},"FEJ","Attachment, Binocular, For Endoscope",{"product_code":480,"device_name":481,"device_class":8,"k510_count":469},"GCW","Transformer, Endoscope",{"product_code":483,"device_name":484,"device_class":8,"k510_count":469},"KDM","Sigmoidoscope, Rigid, Non-Electrical",{"product_code":486,"device_name":487,"device_class":8,"k510_count":469},"KDO","Rongeur, Cystoscopic, Hot",{"product_code":489,"device_name":490,"device_class":8,"k510_count":469},"KYH","Endoscope, Ophthalmic",{"product_code":492,"device_name":493,"device_class":8,"k510_count":469},"MFJ","Device, Endoscopic Suturing",{"product_code":495,"device_name":496,"device_class":8,"k510_count":469},"NWS","Kit, Choledochoscope, Flexible And Rigid",{"product_code":498,"device_name":175,"device_class":8,"k510_count":469},"OCS",{"product_code":500,"device_name":501,"device_class":8,"k510_count":469},"PGU","Spatial Imaging For Display Of Endoscope Position",{"product_code":503,"device_name":504,"device_class":8,"k510_count":469},"PUP","Endoscope Maintenance System",{"product_code":506,"device_name":507,"device_class":8,"k510_count":469},"QGY","Mobile \u002F Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera",{"product_code":509,"device_name":510,"device_class":8,"k510_count":469},"SHU","Appendiceal Scope And Accessories, Flexible",{"product_code":512,"device_name":513,"device_class":12,"k510_count":66},"EXZ","Equipment, Photographic, For Physiologic Function Monitor",{"product_code":515,"device_name":516,"device_class":8,"k510_count":66},"FBI","Rongeur, Cystoscopic",{"product_code":518,"device_name":519,"device_class":12,"k510_count":66},"FCZ","Tube, Smoke Removal, Endoscopic",{"product_code":521,"device_name":522,"device_class":8,"k510_count":66},"FDR","Sphyncteroscope",{"product_code":524,"device_name":525,"device_class":8,"k510_count":66},"FDW","Esophagoscope, Rigid, Gastro-Urology",{"product_code":527,"device_name":528,"device_class":12,"k510_count":66},"FDY","Device, Measuring, For Panendoscope",{"product_code":530,"device_name":531,"device_class":8,"k510_count":66},"FTJ","Colonoscope, General & Plastic Surgery",{"product_code":533,"device_name":534,"device_class":8,"k510_count":66},"GCG","Peritoneoscope",{"product_code":536,"device_name":537,"device_class":8,"k510_count":66},"GCH","Mediastinoscope, Diagnostic",{"product_code":539,"device_name":540,"device_class":8,"k510_count":66},"GCK","Gastroscope, General & Plastic Surgery",{"product_code":542,"device_name":543,"device_class":8,"k510_count":66},"GCN","Endoscope, Prism",{"product_code":545,"device_name":546,"device_class":8,"k510_count":66},"NKZ","Endoilluminator, Reprocessed",{"product_code":548,"device_name":549,"device_class":8,"k510_count":66},"NLX","Needle, Pneumoperitoneum, Spring Loaded, Reprocessed",{"product_code":551,"device_name":552,"device_class":8,"k510_count":66},"NMY","Needle, Endoscopic, Reprocessed",{"product_code":554,"device_name":555,"device_class":8,"k510_count":66},"NWT","Endoscopic Cholangiogram Kit",{"product_code":557,"device_name":558,"device_class":12,"k510_count":66},"PHT","Basin For Endoscope Reprocessing",{"product_code":560,"device_name":561,"device_class":8,"k510_count":66},"PPE","Nephroscope Set",{"product_code":563,"device_name":564,"device_class":8,"k510_count":66},"PTQ","Endoscopic Magnetic Retriever, Exempt",{"product_code":566,"device_name":567,"device_class":8,"k510_count":66},"PTR","Scissors For Cytoscope, Exempt",{"product_code":569,"device_name":570,"device_class":8,"k510_count":66},"PTS","Endoscopic Grasping\u002FCutting Instrument, Non-Powered, Exempt",{"product_code":572,"device_name":573,"device_class":8,"k510_count":66},"SBX","Software For Endoscopy Procedure Metrics",{"510k":575,"classification":576,"enforcement":577,"event":578,"pma":579,"warning_letter":580},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":582,"definition_ja":583,"commentary_ja":584,"model_name":585,"source_hash":586,"reviewed_by":67,"reviewed_at":67,"created_at":587,"updated_at":587},"内視鏡用中央制御装置","内視鏡及びその他の補助的外科用機器を、遠隔操作、タッチスクリーン又は音声コマンドのいずれかにより、一箇所で中央制御するためのものである。","本機器は米国におけるデバイスクラス分類上クラスIIに区分されており、市販前届出（510(k)）による審査を経て市場に流通することになります。510(k)手続きでは、既存の同等品（predicate device）との実質的同等性を示すことが求められ、PMAのような臨床データに基づく厳格な事前承認とは異なる審査プロセスが適用されます。","claude-sonnet-5","562860602ca708651cea8c185617464185d34cebb1ccea805be05b149914d8c9","2026-08-24T02:20:14.132666+00:00",{"product_code":6,"summary_ja":589,"stats":590,"stats_hash":603,"model_name":585,"created_at":604,"updated_at":604},"510(k)の累計件数は約20件で、参入企業数は10社となっています。不具合報告は累計約30件で、大半がMalfunction（不具合）であり、死亡報告は確認されていません。主な問題としてはNo Display\u002FImage、Communication or Transmission Problem、Failure to Power Upが挙げられています。回収については累計件数が0件で、報告はありません。",{"pma":591,"k510":592,"as_of":594,"events":595,"recalls":597,"top_problems":599},{"latest":67,"originals":66,"supplements":66},{"total":68,"last5y":423,"latest":593,"applicants":328},"2023-10-03","2026-08",{"death":66,"other":66,"total":69,"injury":379,"last5y":289,"malfunction":271,"latest_month":596},"2026-07",{"total":66,"last5y":66,"latest":67,"class_i":66,"class_ii":66,"class_iii":66,"top_root_causes":598},[],[600,601,602],"No Display\u002FImage","Communication or Transmission Problem","Failure to Power Up","187e5e8c8b0392448c4cbbdd94166b029a4b8baadb0facc3bfac329fab591b63","2026-08-24T05:01:48.414996+00:00",{"items":606,"total":66},[],{"items":608,"total":68},[609,615,619,623,626,630,634,639,643,646,649,652,655,658,661,664,668,672],{"k_number":31,"device_name":610,"applicant":611,"decision_date":593,"clearance_type":612,"decision_code":613,"statement_or_summary":614},"KARL STORZ OR1 SCB CONTROL (WU300)","Karl Storz SE & CO. KG","Traditional","SESE","Summary",{"k_number":28,"device_name":616,"applicant":617,"decision_date":618,"clearance_type":612,"decision_code":613,"statement_or_summary":614},"Smith+Nephew INTELLIO Tablet","Smith+Nephew","2022-09-06",{"k_number":30,"device_name":620,"applicant":621,"decision_date":622,"clearance_type":612,"decision_code":613,"statement_or_summary":614},"Tablet Application","Smith & Nephew","2021-05-13",{"k_number":18,"device_name":624,"applicant":621,"decision_date":625,"clearance_type":612,"decision_code":613,"statement_or_summary":614},"INTELLIO Tablet Application","2020-02-27",{"k_number":27,"device_name":627,"applicant":628,"decision_date":629,"clearance_type":612,"decision_code":613,"statement_or_summary":614},"IDSS ForceTriad Control Module","Black Diamond Video, Inc.","2016-08-01",{"k_number":29,"device_name":631,"applicant":632,"decision_date":633,"clearance_type":612,"decision_code":613,"statement_or_summary":614},"core nova Complete Operating Room Endoscopy","Richard Wolf Medical Instruments Corp.","2016-01-12",{"k_number":34,"device_name":635,"applicant":636,"decision_date":637,"clearance_type":638,"decision_code":613,"statement_or_summary":614},"KARL STORZ SCB \u002F COVIDIEN FORCETRIAD INTERFACE MODULE","KARL STORZ Endoscopy-America, Inc.","2012-01-06","Special",{"k_number":21,"device_name":640,"applicant":641,"decision_date":642,"clearance_type":638,"decision_code":613,"statement_or_summary":614},"SYSTEMS INTEGRATION","Olympus Medical Systems Corporation","2011-02-15",{"k_number":33,"device_name":644,"applicant":641,"decision_date":645,"clearance_type":638,"decision_code":613,"statement_or_summary":614},"SYSTEMS INTEGRATION MODEL: ENDOALPHA","2010-03-22",{"k_number":20,"device_name":647,"applicant":636,"decision_date":648,"clearance_type":612,"decision_code":613,"statement_or_summary":614},"KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION","2009-05-29",{"k_number":22,"device_name":650,"applicant":636,"decision_date":651,"clearance_type":612,"decision_code":613,"statement_or_summary":614},"KARL STORZ SCB\u002FCONMED ESU INTERFACE MODULE, MODEL 20091522","2008-04-09",{"k_number":25,"device_name":653,"applicant":636,"decision_date":654,"clearance_type":612,"decision_code":613,"statement_or_summary":614},"KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120","2007-05-22",{"k_number":32,"device_name":656,"applicant":641,"decision_date":657,"clearance_type":638,"decision_code":613,"statement_or_summary":614},"MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3","2005-08-15",{"k_number":19,"device_name":659,"applicant":636,"decision_date":660,"clearance_type":612,"decision_code":613,"statement_or_summary":614},"SCB\u002FVALLEYLAB FORCE FX INTERFACE UNIT","2004-10-25",{"k_number":23,"device_name":662,"applicant":632,"decision_date":663,"clearance_type":612,"decision_code":613,"statement_or_summary":614},"RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590","2002-09-18",{"k_number":35,"device_name":665,"applicant":666,"decision_date":667,"clearance_type":638,"decision_code":613,"statement_or_summary":614},"MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA","Olympus Optical Co., Ltd.","2002-08-14",{"k_number":24,"device_name":669,"applicant":670,"decision_date":671,"clearance_type":612,"decision_code":613,"statement_or_summary":614},"SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)","Siemens Medical Corp.","2000-08-10",{"k_number":26,"device_name":673,"applicant":674,"decision_date":675,"clearance_type":612,"decision_code":613,"statement_or_summary":614},"OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA","The Olympus Optical Co.","1998-08-21",{"items":677,"total":66},[]]