[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PUP":3},{"classification":4,"mappedDevices":41,"similarCandidates":42,"relatedClassifications":123,"syncDates":546,"translation":553,"marketSummary":560,"recalls":578,"k510s":580,"pmas":587},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":35,"updated_at":36,"recall_count":37,"latest_recall_date":38,"k510_count":39,"pma_count":37,"event_count":40},3548,"PUP","Endoscope Maintenance System","2","876.1500","GU","Gastroenterology, Urology","HO","4","To assist in disinfecting, rinsing and storing endoscopes or similar elongated instruments.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":32,"device_class":8,"implant_flag":33,"product_code":6,"review_panel":12,"gmp_exempt_flag":33,"third_party_flag":33,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":32,"life_sustain_support_flag":33,"medical_specialty_description":11,"summary_malfunction_reporting":34},{"k_number":18,"fei_number":20,"registration_number":29},[19],"K860246",[21,22,23,24,25,26,27,28],"2150060","1937223","3003950207","3004097451","3012708860","3000251274","3011981638","3006144611",[21,23,25,30,26,27,31,28],"9680353","3034286426","","N","Eligible","2026-08-18T05:52:51.341121+00:00","2026-08-24T02:00:48.620842+00:00",0,null,1,31,[],[43,52,60,68,76,85,93,101,109,116],{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},1786,"内視鏡用送水装置","Ⅱ","36500022",0.414634,0.183333,0.706393,0.0313188,{"medical_device_id":53,"generic_name":54,"class_classification":46,"jmdn_code":55,"name_similarity":56,"definition_similarity":57,"vector_similarity":58,"score":59},1685,"内視鏡ビデオ画像システム","35616000",0.326087,0.132404,0.707329,0.0310245,{"medical_device_id":61,"generic_name":62,"class_classification":46,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},1787,"内視鏡用送気送水装置","36500032",0.354167,0.178947,0.69778,0.0304147,{"medical_device_id":69,"generic_name":70,"class_classification":46,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},1643,"内視鏡用テレスコープ","37084000",0.263158,0.133333,0.720988,0.0303309,{"medical_device_id":77,"generic_name":78,"class_classification":79,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},3461,"内視鏡用レンズ洗浄具","Ⅰ","70167000",0.238095,0.137652,0.721732,0.0290309,{"medical_device_id":86,"generic_name":87,"class_classification":46,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},1772,"超音波内視鏡観測システム","70159000",0.272727,0.126582,0.689321,0.028665,{"medical_device_id":94,"generic_name":95,"class_classification":79,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":100},3483,"内視鏡固定具","37090030",0.25,0.183673,0.6886,0.0278261,{"medical_device_id":102,"generic_name":103,"class_classification":46,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":108},2341,"軟性内視鏡用洗浄消毒器","35628000",0.2,0.194737,0.77357,0.0276294,{"medical_device_id":110,"generic_name":111,"class_classification":46,"jmdn_code":112,"name_similarity":97,"definition_similarity":113,"vector_similarity":114,"score":115},1765,"眼科用内視鏡","70156000",0.17037,0.687419,0.0274436,{"medical_device_id":117,"generic_name":118,"class_classification":46,"jmdn_code":119,"name_similarity":72,"definition_similarity":120,"vector_similarity":121,"score":122},1762,"硬性耳内視鏡","70153000",0.171779,0.678835,0.0266901,[124,128,132,136,140,144,148,152,156,160,164,168,172,176,180,184,188,192,195,199,202,206,210,214,217,221,224,228,232,236,239,243,247,252,255,258,262,266,269,272,276,280,284,288,291,295,298,301,305,308,312,315,318,321,324,328,332,336,339,342,346,349,352,356,359,362,365,368,371,375,378,381,384,387,390,393,396,400,403,406,409,412,415,418,421,424,427,430,433,436,439,442,445,448,451,454,457,460,463,466,469,472,474,477,480,483,486,489,492,495,498,501,504,507,510,513,516,519,522,525,528,531,534,537,540,543],{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"GCJ","Laparoscope, General & Plastic Surgery",1426,{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"NAY","System, Surgical, Computer Controlled Instrument",165,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"FGB","Ureteroscope And Accessories, Flexible\u002FRigid",115,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"FDF","Colonoscope And Accessories, Flexible\u002FRigid",113,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"FED","Endoscopic Access Overtube, Gastroenterology-Urology",102,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"FET","Endoscopic Video Imaging System\u002FComponent, Gastroenterology-Urology",100,{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"OCX","Endoscopic Irrigation\u002FSuction System",93,{"product_code":153,"device_name":154,"device_class":8,"k510_count":155},"FAJ","Cystoscope And Accessories, Flexible\u002FRigid",92,{"product_code":157,"device_name":158,"device_class":8,"k510_count":159},"FBK","Endoscopic Injection Needle, Gastroenterology-Urology",89,{"product_code":161,"device_name":162,"device_class":8,"k510_count":163},"FDS","Gastroscope And Accessories, Flexible\u002FRigid",76,{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"OCZ","Endoscopic Grasping\u002FCutting Instrument, Non-Powered",74,{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"ODC","Endoscope Channel Accessory",72,{"product_code":173,"device_name":174,"device_class":8,"k510_count":175},"OCW","Endoscopic Tissue Approximation Device",70,{"product_code":177,"device_name":178,"device_class":8,"k510_count":179},"OWN","Confocal Optical Imaging",62,{"product_code":181,"device_name":182,"device_class":8,"k510_count":183},"FEB","Accessories, Cleaning, For Endoscope",57,{"product_code":185,"device_name":186,"device_class":8,"k510_count":187},"GCT","Light Source, Endoscope, Xenon Arc",47,{"product_code":189,"device_name":190,"device_class":8,"k510_count":191},"FDX","Endoscopic Cytology Brush",44,{"product_code":193,"device_name":194,"device_class":8,"k510_count":191},"ODG","Endoscopic Ultrasound System, Gastroenterology-Urology",{"product_code":196,"device_name":197,"device_class":8,"k510_count":198},"FBN","Choledochoscope And Accessories, Flexible\u002FRigid",43,{"product_code":200,"device_name":201,"device_class":8,"k510_count":198},"OCY","Endoscopic Guidewire, Gastroenterology-Urology",{"product_code":203,"device_name":204,"device_class":8,"k510_count":205},"LYK","Angioscope",41,{"product_code":207,"device_name":208,"device_class":8,"k510_count":209},"MPA","Endoilluminator",40,{"product_code":211,"device_name":212,"device_class":8,"k510_count":213},"FDT","Duodenoscope And Accessories, Flexible\u002FRigid",35,{"product_code":215,"device_name":216,"device_class":8,"k510_count":40},"FCW","Light Source, Fiberoptic, Routine",{"product_code":218,"device_name":219,"device_class":8,"k510_count":220},"FER","Anoscope And Accessories",27,{"product_code":222,"device_name":223,"device_class":8,"k510_count":220},"OCT","Anti Fog Solution And Accessories, Endoscopy",{"product_code":225,"device_name":226,"device_class":8,"k510_count":227},"FFS","Image, Illumination, Fiberoptic, For Endoscope ",26,{"product_code":229,"device_name":230,"device_class":8,"k510_count":231},"FCX","Insufflator, Automatic Carbon-Dioxide For Endoscope",25,{"product_code":233,"device_name":234,"device_class":8,"k510_count":235},"FAM","Sigmoidoscope And Accessories, Flexible\u002FRigid",24,{"product_code":237,"device_name":238,"device_class":8,"k510_count":235},"FJL","Resectoscope",{"product_code":240,"device_name":241,"device_class":8,"k510_count":242},"NLM","Laparoscope, General & Plastic Surgery, Reprocessed",23,{"product_code":244,"device_name":245,"device_class":8,"k510_count":246},"FEQ","Pump, Air, Non-Manual, For Endoscope",21,{"product_code":248,"device_name":249,"device_class":250,"k510_count":251},"FCO","Box, Battery, Rechargeable","1",20,{"product_code":253,"device_name":254,"device_class":8,"k510_count":251},"FDA","Enteroscope And Accessories",{"product_code":256,"device_name":257,"device_class":8,"k510_count":251},"ODE","Endoscopic Suture\u002FPlication System, Gastroesophageal Reflux Disease (Gerd)",{"product_code":259,"device_name":260,"device_class":8,"k510_count":261},"FBO","Cystourethroscope",19,{"product_code":263,"device_name":264,"device_class":8,"k510_count":265},"GCM","Endoscope, Rigid",18,{"product_code":267,"device_name":268,"device_class":8,"k510_count":265},"ODA","Endoscopic Central Control Unit",{"product_code":270,"device_name":271,"device_class":8,"k510_count":265},"ODD","Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula",{"product_code":273,"device_name":274,"device_class":8,"k510_count":275},"FHO","Pneumoperitoneum Needle",15,{"product_code":277,"device_name":278,"device_class":8,"k510_count":279},"GCI","Laryngoscope, Endoscope",14,{"product_code":281,"device_name":282,"device_class":8,"k510_count":283},"GCP","Endoscope, Ac-Powered And Accessories",13,{"product_code":285,"device_name":286,"device_class":8,"k510_count":287},"NVE","Washer, Cleaner, Automated, Endoscope",12,{"product_code":289,"device_name":290,"device_class":8,"k510_count":287},"ODF","Mini Endoscope, Gastroenterology-Urology",{"product_code":292,"device_name":293,"device_class":8,"k510_count":294},"FDC","Resectoscope, Working Element",11,{"product_code":296,"device_name":297,"device_class":8,"k510_count":294},"NZA","Accessories, Germicide, Cleaning, For Endoscopes",{"product_code":299,"device_name":300,"device_class":8,"k510_count":294},"OTJ","Laparoscopic Single Port Access Device",{"product_code":302,"device_name":303,"device_class":8,"k510_count":304},"FGA","Kit, Nephroscope",10,{"product_code":306,"device_name":307,"device_class":8,"k510_count":304},"OCV","Endoscope Holder",{"product_code":309,"device_name":310,"device_class":8,"k510_count":311},"GCS","Endoscope, Battery-Powered And Accessories",9,{"product_code":313,"device_name":314,"device_class":8,"k510_count":311},"NTN","Led Light Source",{"product_code":316,"device_name":317,"device_class":8,"k510_count":311},"NWB","Endoscope, Accessories, Narrow Band Spectrum",{"product_code":319,"device_name":320,"device_class":8,"k510_count":311},"PEA","Endoscope, Accessories, Image Post-Processing For Color Enhancement",{"product_code":322,"device_name":323,"device_class":8,"k510_count":311},"PLL","Submucosal Injection Agent",{"product_code":325,"device_name":326,"device_class":8,"k510_count":327},"QSM","System, Surgical, Computer Controlled Instrument, Remanufactured",8,{"product_code":329,"device_name":330,"device_class":8,"k510_count":331},"GDB","Endoscope, Fiber Optic",7,{"product_code":333,"device_name":334,"device_class":8,"k510_count":335},"FHX","Jelly, Lubricating, For Transurethral Surgical Instrument",6,{"product_code":337,"device_name":338,"device_class":250,"k510_count":335},"MNK","Endoscopic Bite Block",{"product_code":340,"device_name":341,"device_class":8,"k510_count":335},"OCU","Endoscopic Storage Cover",{"product_code":343,"device_name":344,"device_class":8,"k510_count":345},"FBP","Telescope, Rigid, Endoscopic",5,{"product_code":347,"device_name":348,"device_class":8,"k510_count":345},"GCQ","Endoscope, Flexible",{"product_code":350,"device_name":351,"device_class":8,"k510_count":345},"ODB","Endoscopic Contamination Prevention Sheath",{"product_code":353,"device_name":354,"device_class":8,"k510_count":355},"FDE","Laparoscopy Kit",4,{"product_code":357,"device_name":358,"device_class":250,"k510_count":355},"FEM","Accessories, Photographic, For Endoscope (Exclude Light Sources)",{"product_code":360,"device_name":361,"device_class":8,"k510_count":355},"FGS","Carrier, Sponge, Endoscopic",{"product_code":363,"device_name":364,"device_class":8,"k510_count":355},"GCL","Esophagoscope, General & Plastic Surgery",{"product_code":366,"device_name":367,"device_class":250,"k510_count":355},"MNL","Accessories, Cleaning Brushes, For Endoscope",{"product_code":369,"device_name":370,"device_class":8,"k510_count":355},"QZB","Software Controlled Endoscope And Instrument Holder",{"product_code":372,"device_name":373,"device_class":8,"k510_count":374},"FCC","Endoscopic Magnetic Retriever",3,{"product_code":376,"device_name":377,"device_class":8,"k510_count":374},"FCR","Light Source, Photographic, Fiberoptic",{"product_code":379,"device_name":380,"device_class":250,"k510_count":374},"FCY","Bulb, Inflation, For Endoscope",{"product_code":382,"device_name":383,"device_class":8,"k510_count":374},"FEC","Obturator, For Endoscope",{"product_code":385,"device_name":386,"device_class":8,"k510_count":374},"FFZ","Cord, Electric, For Endoscope",{"product_code":388,"device_name":389,"device_class":8,"k510_count":374},"FGC","Urethroscope",{"product_code":391,"device_name":392,"device_class":8,"k510_count":374},"GCO","Endoscope, Mirror",{"product_code":394,"device_name":395,"device_class":8,"k510_count":374},"NWU","Endoscope Introducer Kit",{"product_code":397,"device_name":398,"device_class":8,"k510_count":399},"FAK","Panendoscope (Gastroduodenoscope)",2,{"product_code":401,"device_name":402,"device_class":8,"k510_count":399},"FAN","Sigmoidoscope, Rigid, Electrical",{"product_code":404,"device_name":405,"device_class":250,"k510_count":399},"FCP","Box, Battery, Pocket",{"product_code":407,"device_name":408,"device_class":250,"k510_count":399},"FDZ","Attachment, Eyepiece, For Insertion Of Prescription Lens",{"product_code":410,"device_name":411,"device_class":250,"k510_count":399},"FEA","Attachment, Teaching, For Endoscope",{"product_code":413,"device_name":414,"device_class":250,"k510_count":399},"FEI","Instrument, Special Lens, For Endoscope",{"product_code":416,"device_name":417,"device_class":250,"k510_count":399},"FFY","Adaptor, Bulbs, Miscellaneous, For Endoscope",{"product_code":419,"device_name":420,"device_class":8,"k510_count":399},"FHP","Needle, Pneumoperitoneum, Simple",{"product_code":422,"device_name":423,"device_class":8,"k510_count":399},"FTI","Lamp, Endoscope, Incandescent",{"product_code":425,"device_name":426,"device_class":8,"k510_count":399},"GCF","Proctoscope",{"product_code":428,"device_name":429,"device_class":8,"k510_count":399},"KGD","Scissors For Cystoscope",{"product_code":431,"device_name":432,"device_class":8,"k510_count":399},"NBG","Marker, Colon",{"product_code":434,"device_name":435,"device_class":8,"k510_count":399},"NEQ","Device, Telemedicine, Robotic",{"product_code":437,"device_name":438,"device_class":8,"k510_count":399},"PCV","Endoscopic Leak Tester",{"product_code":440,"device_name":441,"device_class":8,"k510_count":399},"SFE","Endoscopic Video Imaging System \u002F Software Component For Real Time Video Augmentation",{"product_code":443,"device_name":444,"device_class":8,"k510_count":39},"FAL","Panendoscope (Urethroscope)",{"product_code":446,"device_name":447,"device_class":8,"k510_count":39},"FCQ","Light Source, Incandescent, Diagnostic",{"product_code":449,"device_name":450,"device_class":8,"k510_count":39},"FDP","Apparatus, Pneumoperitoneum, Automatic",{"product_code":452,"device_name":453,"device_class":250,"k510_count":39},"FEJ","Attachment, Binocular, For Endoscope",{"product_code":455,"device_name":456,"device_class":8,"k510_count":39},"GCW","Transformer, Endoscope",{"product_code":458,"device_name":459,"device_class":8,"k510_count":39},"KDM","Sigmoidoscope, Rigid, Non-Electrical",{"product_code":461,"device_name":462,"device_class":8,"k510_count":39},"KDO","Rongeur, Cystoscopic, Hot",{"product_code":464,"device_name":465,"device_class":8,"k510_count":39},"KYH","Endoscope, Ophthalmic",{"product_code":467,"device_name":468,"device_class":8,"k510_count":39},"MFJ","Device, Endoscopic Suturing",{"product_code":470,"device_name":471,"device_class":8,"k510_count":39},"NWS","Kit, Choledochoscope, Flexible And Rigid",{"product_code":473,"device_name":146,"device_class":8,"k510_count":39},"OCS",{"product_code":475,"device_name":476,"device_class":8,"k510_count":39},"PGU","Spatial Imaging For Display Of Endoscope Position",{"product_code":478,"device_name":479,"device_class":8,"k510_count":39},"QGY","Mobile \u002F Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera",{"product_code":481,"device_name":482,"device_class":8,"k510_count":39},"SHU","Appendiceal Scope And Accessories, Flexible",{"product_code":484,"device_name":485,"device_class":250,"k510_count":37},"EXZ","Equipment, Photographic, For Physiologic Function Monitor",{"product_code":487,"device_name":488,"device_class":8,"k510_count":37},"FBI","Rongeur, Cystoscopic",{"product_code":490,"device_name":491,"device_class":250,"k510_count":37},"FCZ","Tube, Smoke Removal, Endoscopic",{"product_code":493,"device_name":494,"device_class":8,"k510_count":37},"FDR","Sphyncteroscope",{"product_code":496,"device_name":497,"device_class":8,"k510_count":37},"FDW","Esophagoscope, Rigid, Gastro-Urology",{"product_code":499,"device_name":500,"device_class":250,"k510_count":37},"FDY","Device, Measuring, For Panendoscope",{"product_code":502,"device_name":503,"device_class":8,"k510_count":37},"FTJ","Colonoscope, General & Plastic Surgery",{"product_code":505,"device_name":506,"device_class":8,"k510_count":37},"GCG","Peritoneoscope",{"product_code":508,"device_name":509,"device_class":8,"k510_count":37},"GCH","Mediastinoscope, Diagnostic",{"product_code":511,"device_name":512,"device_class":8,"k510_count":37},"GCK","Gastroscope, General & Plastic Surgery",{"product_code":514,"device_name":515,"device_class":8,"k510_count":37},"GCN","Endoscope, Prism",{"product_code":517,"device_name":518,"device_class":8,"k510_count":37},"NKZ","Endoilluminator, Reprocessed",{"product_code":520,"device_name":521,"device_class":8,"k510_count":37},"NLX","Needle, Pneumoperitoneum, Spring Loaded, Reprocessed",{"product_code":523,"device_name":524,"device_class":8,"k510_count":37},"NMY","Needle, Endoscopic, Reprocessed",{"product_code":526,"device_name":527,"device_class":8,"k510_count":37},"NWT","Endoscopic Cholangiogram Kit",{"product_code":529,"device_name":530,"device_class":250,"k510_count":37},"PHT","Basin For Endoscope Reprocessing",{"product_code":532,"device_name":533,"device_class":8,"k510_count":37},"PPE","Nephroscope Set",{"product_code":535,"device_name":536,"device_class":8,"k510_count":37},"PTQ","Endoscopic Magnetic Retriever, Exempt",{"product_code":538,"device_name":539,"device_class":8,"k510_count":37},"PTR","Scissors For Cytoscope, Exempt",{"product_code":541,"device_name":542,"device_class":8,"k510_count":37},"PTS","Endoscopic Grasping\u002FCutting Instrument, Non-Powered, Exempt",{"product_code":544,"device_name":545,"device_class":8,"k510_count":37},"SBX","Software For Endoscopy Procedure Metrics",{"510k":547,"classification":548,"enforcement":549,"event":550,"pma":551,"warning_letter":552},"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":554,"definition_ja":555,"commentary_ja":556,"model_name":557,"source_hash":558,"reviewed_by":38,"reviewed_at":38,"created_at":559,"updated_at":559},"内視鏡メンテナンスシステム","内視鏡又は類似の細長い器具の消毒、すすぎ及び保管を補助するためのものである。","本品は米国においてクラスIIに分類される医療機器です。クラスIIは中程度のリスクを有する機器区分ですが、本品は21 CFR 876.1500の規定により市販前届出（510(k)）が免除されており、届出を行うことなく市販することが可能です。","claude-sonnet-5","539658eb68fe9fe81b4fdac3d13b2cbc9de8b694f92813935f575028644411f5","2026-08-24T02:33:49.041043+00:00",{"product_code":6,"summary_ja":561,"stats":562,"stats_hash":576,"model_name":557,"created_at":577,"updated_at":577},"本製品は届出免除区分ですが、510(k)の累計届出は1件で、直近5年間の届出はありません。不具合報告は累計約30件で、大半がMalfunction（不具合）であり、傷害報告が3件含まれ、死亡報告は確認されていません。主な問題としては、鋭利な端部（Sharp Edges）、装置または部品の脱落（Detachment of Device or Device Component）、手技の不適切または誤り（Improper or Incorrect Procedure or Method）が挙げられています。回収については累計件数は確認されていません。",{"pma":563,"k510":564,"as_of":566,"events":567,"recalls":570,"top_problems":572},{"latest":38,"originals":37,"supplements":37},{"total":39,"last5y":37,"latest":565,"applicants":39},"1986-04-02","2026-08",{"death":37,"other":37,"total":40,"injury":374,"last5y":220,"malfunction":568,"latest_month":569},28,"2026-07",{"total":37,"last5y":37,"latest":38,"class_i":37,"class_ii":37,"class_iii":37,"top_root_causes":571},[],[573,574,575],"Sharp Edges","Detachment of Device or Device Component","Improper or Incorrect Procedure or Method","7e1ee05e91e3a002f07b4114ee5a7abc6ccd313427457f5dbecdd0cd7c3c0f02","2026-08-24T05:15:00.389328+00:00",{"items":579,"total":37},[],{"items":581,"total":39},[582],{"k_number":19,"device_name":583,"applicant":584,"decision_date":565,"clearance_type":585,"decision_code":586,"statement_or_summary":38},"ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE","Buckman Co., Inc.","Traditional","SESE",{"items":588,"total":37},[]]