[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OTJ":3},{"classification":4,"mappedDevices":48,"similarCandidates":49,"relatedClassifications":130,"syncDates":552,"translation":559,"marketSummary":566,"recalls":583,"k510s":585,"pmas":631},{"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":42,"updated_at":43,"recall_count":44,"latest_recall_date":45,"k510_count":46,"pma_count":44,"event_count":47},6566,"OTJ","Laparoscopic Single Port Access Device","2","876.1500","GU","Gastroenterology, Urology","SU","1","A multiple instrument and\u002For camera port during minimally invasive abdominal laparoscopic surgery.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":39,"device_class":8,"implant_flag":40,"product_code":6,"review_panel":12,"gmp_exempt_flag":40,"third_party_flag":40,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":39,"life_sustain_support_flag":40,"medical_specialty_description":11,"summary_malfunction_reporting":41},{"k_number":18,"fei_number":30,"registration_number":37},[19,20,21,22,23,24,25,26,27,28,29],"K112196","K232062","K152598","K121309","K120898","K202688","K160797","K220081","K111407","K101794","K110004",[31,32,33,34,35,36],"2219920","3020347456","1418479","3010370500","1220351","3002808001",[38,31,32,33,34,35],"9611102","","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:48.758894+00:00",0,null,11,18,[],[50,59,67,75,83,91,99,107,115,123],{"medical_device_id":51,"generic_name":52,"class_classification":53,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},2260,"腹腔鏡用ガス気腹装置","Ⅱ","70447000",0.305085,0.130252,0.674458,0.0274927,{"medical_device_id":60,"generic_name":61,"class_classification":53,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},1793,"単回使用内視鏡用能動処置具","38817000",0.266667,0.119565,0.679587,0.0273466,{"medical_device_id":68,"generic_name":69,"class_classification":53,"jmdn_code":70,"name_similarity":71,"definition_similarity":72,"vector_similarity":73,"score":74},1688,"ビデオ軟性腹腔鏡","36283000",0.2,0.145161,0.708507,0.0267361,{"medical_device_id":76,"generic_name":77,"class_classification":53,"jmdn_code":78,"name_similarity":79,"definition_similarity":80,"vector_similarity":81,"score":82},1840,"単回使用内視鏡用注射針","38825000",0.203125,0.144,0.70352,0.0265152,{"medical_device_id":84,"generic_name":85,"class_classification":53,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},1666,"軟性腹腔鏡","70106000",0.22449,0.148289,0.681392,0.0263569,{"medical_device_id":92,"generic_name":93,"class_classification":53,"jmdn_code":94,"name_similarity":95,"definition_similarity":96,"vector_similarity":97,"score":98},1730,"硬性腹腔鏡","12291000",0.212766,0.135922,0.686849,0.026334,{"medical_device_id":100,"generic_name":101,"class_classification":53,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":106},1802,"人工開口向け単回使用内視鏡用非能動処置具","38819002",0.21519,0.100592,0.687301,0.0257468,{"medical_device_id":108,"generic_name":109,"class_classification":53,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},1770,"超音波軟性腹腔鏡","70157000",0.20339,0.149378,0.678997,0.0236761,{"medical_device_id":116,"generic_name":117,"class_classification":53,"jmdn_code":118,"name_similarity":119,"definition_similarity":120,"vector_similarity":121,"score":122},1806,"腹腔鏡用病変部吊り上げ具","70175000",0.411765,0.150838,0.665657,0.0163934,{"medical_device_id":124,"generic_name":125,"class_classification":53,"jmdn_code":126,"name_similarity":127,"definition_similarity":128,"vector_similarity":129,"score":122},1878,"単回使用胸膜腹膜用針","12750002",0.123077,0.0852273,0.722871,[131,135,139,143,147,151,155,159,163,167,171,175,179,183,187,191,195,199,202,206,209,213,217,221,225,229,232,236,240,244,247,251,255,259,262,265,269,272,275,278,282,286,290,294,297,300,303,307,310,314,317,320,323,326,330,334,338,341,344,348,351,354,358,361,364,367,370,373,377,380,383,386,389,392,395,398,402,405,408,411,414,417,420,423,426,429,432,435,438,441,444,448,451,454,457,460,463,466,469,472,475,477,480,483,486,489,492,495,498,501,504,507,510,513,516,519,522,525,528,531,534,537,540,543,546,549],{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"GCJ","Laparoscope, General & Plastic Surgery",1426,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"NAY","System, Surgical, Computer Controlled Instrument",165,{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"FGB","Ureteroscope And Accessories, Flexible\u002FRigid",115,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"FDF","Colonoscope And Accessories, Flexible\u002FRigid",113,{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"FED","Endoscopic Access Overtube, Gastroenterology-Urology",102,{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"FET","Endoscopic Video Imaging System\u002FComponent, Gastroenterology-Urology",100,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"OCX","Endoscopic Irrigation\u002FSuction System",93,{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"FAJ","Cystoscope And Accessories, Flexible\u002FRigid",92,{"product_code":164,"device_name":165,"device_class":8,"k510_count":166},"FBK","Endoscopic Injection Needle, Gastroenterology-Urology",89,{"product_code":168,"device_name":169,"device_class":8,"k510_count":170},"FDS","Gastroscope And Accessories, Flexible\u002FRigid",76,{"product_code":172,"device_name":173,"device_class":8,"k510_count":174},"OCZ","Endoscopic Grasping\u002FCutting Instrument, Non-Powered",74,{"product_code":176,"device_name":177,"device_class":8,"k510_count":178},"ODC","Endoscope Channel Accessory",72,{"product_code":180,"device_name":181,"device_class":8,"k510_count":182},"OCW","Endoscopic Tissue Approximation Device",70,{"product_code":184,"device_name":185,"device_class":8,"k510_count":186},"OWN","Confocal Optical Imaging",62,{"product_code":188,"device_name":189,"device_class":8,"k510_count":190},"FEB","Accessories, Cleaning, For Endoscope",57,{"product_code":192,"device_name":193,"device_class":8,"k510_count":194},"GCT","Light Source, Endoscope, Xenon Arc",47,{"product_code":196,"device_name":197,"device_class":8,"k510_count":198},"FDX","Endoscopic Cytology Brush",44,{"product_code":200,"device_name":201,"device_class":8,"k510_count":198},"ODG","Endoscopic Ultrasound System, Gastroenterology-Urology",{"product_code":203,"device_name":204,"device_class":8,"k510_count":205},"FBN","Choledochoscope And Accessories, Flexible\u002FRigid",43,{"product_code":207,"device_name":208,"device_class":8,"k510_count":205},"OCY","Endoscopic Guidewire, Gastroenterology-Urology",{"product_code":210,"device_name":211,"device_class":8,"k510_count":212},"LYK","Angioscope",41,{"product_code":214,"device_name":215,"device_class":8,"k510_count":216},"MPA","Endoilluminator",40,{"product_code":218,"device_name":219,"device_class":8,"k510_count":220},"FDT","Duodenoscope And Accessories, Flexible\u002FRigid",35,{"product_code":222,"device_name":223,"device_class":8,"k510_count":224},"FCW","Light Source, Fiberoptic, Routine",31,{"product_code":226,"device_name":227,"device_class":8,"k510_count":228},"FER","Anoscope And Accessories",27,{"product_code":230,"device_name":231,"device_class":8,"k510_count":228},"OCT","Anti Fog Solution And Accessories, Endoscopy",{"product_code":233,"device_name":234,"device_class":8,"k510_count":235},"FFS","Image, Illumination, Fiberoptic, For Endoscope ",26,{"product_code":237,"device_name":238,"device_class":8,"k510_count":239},"FCX","Insufflator, Automatic Carbon-Dioxide For Endoscope",25,{"product_code":241,"device_name":242,"device_class":8,"k510_count":243},"FAM","Sigmoidoscope And Accessories, Flexible\u002FRigid",24,{"product_code":245,"device_name":246,"device_class":8,"k510_count":243},"FJL","Resectoscope",{"product_code":248,"device_name":249,"device_class":8,"k510_count":250},"NLM","Laparoscope, General & Plastic Surgery, Reprocessed",23,{"product_code":252,"device_name":253,"device_class":8,"k510_count":254},"FEQ","Pump, Air, Non-Manual, For Endoscope",21,{"product_code":256,"device_name":257,"device_class":13,"k510_count":258},"FCO","Box, Battery, Rechargeable",20,{"product_code":260,"device_name":261,"device_class":8,"k510_count":258},"FDA","Enteroscope And Accessories",{"product_code":263,"device_name":264,"device_class":8,"k510_count":258},"ODE","Endoscopic Suture\u002FPlication System, Gastroesophageal Reflux Disease (Gerd)",{"product_code":266,"device_name":267,"device_class":8,"k510_count":268},"FBO","Cystourethroscope",19,{"product_code":270,"device_name":271,"device_class":8,"k510_count":47},"GCM","Endoscope, Rigid",{"product_code":273,"device_name":274,"device_class":8,"k510_count":47},"ODA","Endoscopic Central Control Unit",{"product_code":276,"device_name":277,"device_class":8,"k510_count":47},"ODD","Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula",{"product_code":279,"device_name":280,"device_class":8,"k510_count":281},"FHO","Pneumoperitoneum Needle",15,{"product_code":283,"device_name":284,"device_class":8,"k510_count":285},"GCI","Laryngoscope, Endoscope",14,{"product_code":287,"device_name":288,"device_class":8,"k510_count":289},"GCP","Endoscope, Ac-Powered And Accessories",13,{"product_code":291,"device_name":292,"device_class":8,"k510_count":293},"NVE","Washer, Cleaner, Automated, Endoscope",12,{"product_code":295,"device_name":296,"device_class":8,"k510_count":293},"ODF","Mini Endoscope, Gastroenterology-Urology",{"product_code":298,"device_name":299,"device_class":8,"k510_count":46},"FDC","Resectoscope, Working Element",{"product_code":301,"device_name":302,"device_class":8,"k510_count":46},"NZA","Accessories, Germicide, Cleaning, For Endoscopes",{"product_code":304,"device_name":305,"device_class":8,"k510_count":306},"FGA","Kit, Nephroscope",10,{"product_code":308,"device_name":309,"device_class":8,"k510_count":306},"OCV","Endoscope Holder",{"product_code":311,"device_name":312,"device_class":8,"k510_count":313},"GCS","Endoscope, Battery-Powered And Accessories",9,{"product_code":315,"device_name":316,"device_class":8,"k510_count":313},"NTN","Led Light Source",{"product_code":318,"device_name":319,"device_class":8,"k510_count":313},"NWB","Endoscope, Accessories, Narrow Band Spectrum",{"product_code":321,"device_name":322,"device_class":8,"k510_count":313},"PEA","Endoscope, Accessories, Image Post-Processing For Color Enhancement",{"product_code":324,"device_name":325,"device_class":8,"k510_count":313},"PLL","Submucosal Injection Agent",{"product_code":327,"device_name":328,"device_class":8,"k510_count":329},"QSM","System, Surgical, Computer Controlled Instrument, Remanufactured",8,{"product_code":331,"device_name":332,"device_class":8,"k510_count":333},"GDB","Endoscope, Fiber Optic",7,{"product_code":335,"device_name":336,"device_class":8,"k510_count":337},"FHX","Jelly, Lubricating, For Transurethral Surgical Instrument",6,{"product_code":339,"device_name":340,"device_class":13,"k510_count":337},"MNK","Endoscopic Bite Block",{"product_code":342,"device_name":343,"device_class":8,"k510_count":337},"OCU","Endoscopic Storage Cover",{"product_code":345,"device_name":346,"device_class":8,"k510_count":347},"FBP","Telescope, Rigid, Endoscopic",5,{"product_code":349,"device_name":350,"device_class":8,"k510_count":347},"GCQ","Endoscope, Flexible",{"product_code":352,"device_name":353,"device_class":8,"k510_count":347},"ODB","Endoscopic Contamination Prevention Sheath",{"product_code":355,"device_name":356,"device_class":8,"k510_count":357},"FDE","Laparoscopy Kit",4,{"product_code":359,"device_name":360,"device_class":13,"k510_count":357},"FEM","Accessories, Photographic, For Endoscope (Exclude Light Sources)",{"product_code":362,"device_name":363,"device_class":8,"k510_count":357},"FGS","Carrier, Sponge, Endoscopic",{"product_code":365,"device_name":366,"device_class":8,"k510_count":357},"GCL","Esophagoscope, General & Plastic Surgery",{"product_code":368,"device_name":369,"device_class":13,"k510_count":357},"MNL","Accessories, Cleaning Brushes, For Endoscope",{"product_code":371,"device_name":372,"device_class":8,"k510_count":357},"QZB","Software Controlled Endoscope And Instrument Holder",{"product_code":374,"device_name":375,"device_class":8,"k510_count":376},"FCC","Endoscopic Magnetic Retriever",3,{"product_code":378,"device_name":379,"device_class":8,"k510_count":376},"FCR","Light Source, Photographic, Fiberoptic",{"product_code":381,"device_name":382,"device_class":13,"k510_count":376},"FCY","Bulb, Inflation, For Endoscope",{"product_code":384,"device_name":385,"device_class":8,"k510_count":376},"FEC","Obturator, For Endoscope",{"product_code":387,"device_name":388,"device_class":8,"k510_count":376},"FFZ","Cord, Electric, For Endoscope",{"product_code":390,"device_name":391,"device_class":8,"k510_count":376},"FGC","Urethroscope",{"product_code":393,"device_name":394,"device_class":8,"k510_count":376},"GCO","Endoscope, Mirror",{"product_code":396,"device_name":397,"device_class":8,"k510_count":376},"NWU","Endoscope Introducer Kit",{"product_code":399,"device_name":400,"device_class":8,"k510_count":401},"FAK","Panendoscope (Gastroduodenoscope)",2,{"product_code":403,"device_name":404,"device_class":8,"k510_count":401},"FAN","Sigmoidoscope, Rigid, Electrical",{"product_code":406,"device_name":407,"device_class":13,"k510_count":401},"FCP","Box, Battery, Pocket",{"product_code":409,"device_name":410,"device_class":13,"k510_count":401},"FDZ","Attachment, Eyepiece, For Insertion Of Prescription Lens",{"product_code":412,"device_name":413,"device_class":13,"k510_count":401},"FEA","Attachment, Teaching, For Endoscope",{"product_code":415,"device_name":416,"device_class":13,"k510_count":401},"FEI","Instrument, Special Lens, For Endoscope",{"product_code":418,"device_name":419,"device_class":13,"k510_count":401},"FFY","Adaptor, Bulbs, Miscellaneous, For Endoscope",{"product_code":421,"device_name":422,"device_class":8,"k510_count":401},"FHP","Needle, Pneumoperitoneum, Simple",{"product_code":424,"device_name":425,"device_class":8,"k510_count":401},"FTI","Lamp, Endoscope, Incandescent",{"product_code":427,"device_name":428,"device_class":8,"k510_count":401},"GCF","Proctoscope",{"product_code":430,"device_name":431,"device_class":8,"k510_count":401},"KGD","Scissors For Cystoscope",{"product_code":433,"device_name":434,"device_class":8,"k510_count":401},"NBG","Marker, Colon",{"product_code":436,"device_name":437,"device_class":8,"k510_count":401},"NEQ","Device, Telemedicine, Robotic",{"product_code":439,"device_name":440,"device_class":8,"k510_count":401},"PCV","Endoscopic Leak Tester",{"product_code":442,"device_name":443,"device_class":8,"k510_count":401},"SFE","Endoscopic Video Imaging System \u002F Software Component For Real Time Video Augmentation",{"product_code":445,"device_name":446,"device_class":8,"k510_count":447},"FAL","Panendoscope (Urethroscope)",1,{"product_code":449,"device_name":450,"device_class":8,"k510_count":447},"FCQ","Light Source, Incandescent, Diagnostic",{"product_code":452,"device_name":453,"device_class":8,"k510_count":447},"FDP","Apparatus, Pneumoperitoneum, Automatic",{"product_code":455,"device_name":456,"device_class":13,"k510_count":447},"FEJ","Attachment, Binocular, For Endoscope",{"product_code":458,"device_name":459,"device_class":8,"k510_count":447},"GCW","Transformer, Endoscope",{"product_code":461,"device_name":462,"device_class":8,"k510_count":447},"KDM","Sigmoidoscope, Rigid, Non-Electrical",{"product_code":464,"device_name":465,"device_class":8,"k510_count":447},"KDO","Rongeur, Cystoscopic, Hot",{"product_code":467,"device_name":468,"device_class":8,"k510_count":447},"KYH","Endoscope, Ophthalmic",{"product_code":470,"device_name":471,"device_class":8,"k510_count":447},"MFJ","Device, Endoscopic Suturing",{"product_code":473,"device_name":474,"device_class":8,"k510_count":447},"NWS","Kit, Choledochoscope, Flexible And Rigid",{"product_code":476,"device_name":153,"device_class":8,"k510_count":447},"OCS",{"product_code":478,"device_name":479,"device_class":8,"k510_count":447},"PGU","Spatial Imaging For Display Of Endoscope Position",{"product_code":481,"device_name":482,"device_class":8,"k510_count":447},"PUP","Endoscope Maintenance System",{"product_code":484,"device_name":485,"device_class":8,"k510_count":447},"QGY","Mobile \u002F Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera",{"product_code":487,"device_name":488,"device_class":8,"k510_count":447},"SHU","Appendiceal Scope And Accessories, Flexible",{"product_code":490,"device_name":491,"device_class":13,"k510_count":44},"EXZ","Equipment, Photographic, For Physiologic Function Monitor",{"product_code":493,"device_name":494,"device_class":8,"k510_count":44},"FBI","Rongeur, Cystoscopic",{"product_code":496,"device_name":497,"device_class":13,"k510_count":44},"FCZ","Tube, Smoke Removal, Endoscopic",{"product_code":499,"device_name":500,"device_class":8,"k510_count":44},"FDR","Sphyncteroscope",{"product_code":502,"device_name":503,"device_class":8,"k510_count":44},"FDW","Esophagoscope, Rigid, Gastro-Urology",{"product_code":505,"device_name":506,"device_class":13,"k510_count":44},"FDY","Device, Measuring, For Panendoscope",{"product_code":508,"device_name":509,"device_class":8,"k510_count":44},"FTJ","Colonoscope, General & Plastic Surgery",{"product_code":511,"device_name":512,"device_class":8,"k510_count":44},"GCG","Peritoneoscope",{"product_code":514,"device_name":515,"device_class":8,"k510_count":44},"GCH","Mediastinoscope, Diagnostic",{"product_code":517,"device_name":518,"device_class":8,"k510_count":44},"GCK","Gastroscope, General & Plastic Surgery",{"product_code":520,"device_name":521,"device_class":8,"k510_count":44},"GCN","Endoscope, Prism",{"product_code":523,"device_name":524,"device_class":8,"k510_count":44},"NKZ","Endoilluminator, Reprocessed",{"product_code":526,"device_name":527,"device_class":8,"k510_count":44},"NLX","Needle, Pneumoperitoneum, Spring Loaded, Reprocessed",{"product_code":529,"device_name":530,"device_class":8,"k510_count":44},"NMY","Needle, Endoscopic, Reprocessed",{"product_code":532,"device_name":533,"device_class":8,"k510_count":44},"NWT","Endoscopic Cholangiogram Kit",{"product_code":535,"device_name":536,"device_class":13,"k510_count":44},"PHT","Basin For Endoscope Reprocessing",{"product_code":538,"device_name":539,"device_class":8,"k510_count":44},"PPE","Nephroscope Set",{"product_code":541,"device_name":542,"device_class":8,"k510_count":44},"PTQ","Endoscopic Magnetic Retriever, Exempt",{"product_code":544,"device_name":545,"device_class":8,"k510_count":44},"PTR","Scissors For Cytoscope, Exempt",{"product_code":547,"device_name":548,"device_class":8,"k510_count":44},"PTS","Endoscopic Grasping\u002FCutting Instrument, Non-Powered, Exempt",{"product_code":550,"device_name":551,"device_class":8,"k510_count":44},"SBX","Software For Endoscopy Procedure Metrics",{"510k":553,"classification":554,"enforcement":555,"event":556,"pma":557,"warning_letter":558},"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":560,"definition_ja":561,"commentary_ja":562,"model_name":563,"source_hash":564,"reviewed_by":45,"reviewed_at":45,"created_at":565,"updated_at":565},"腹腔鏡下単孔式アクセスデバイス","低侵襲腹部腹腔鏡手術中における、複数の器具及び／又はカメラ用ポートである。","米国ではクラスIIに分類されており、市販前届出（510(k)）の対象として、既存の同等な機器との実質的同等性を示すことにより市販が認められる審査区分に該当します。クラスIIは、クラスIより高いリスクを有するものの、性能規格や適切な管理措置により安全性・有効性が確保できると考えられる中リスクの医療機器を指す区分です。","claude-sonnet-5","51f8af44751cffdc401700641e7ecf2e88dc5357ebdeb4756476f7a8a4a427ec","2026-08-24T02:26:34.466715+00:00",{"product_code":6,"summary_ja":567,"stats":568,"stats_hash":581,"model_name":563,"created_at":582,"updated_at":582},"510(k)の累計件数は約10件、参入企業数は8社で、直近5年間では約3件の届出が確認されています。不具合報告は累計約20件で、大半がMalfunction（不具合）であり、傷害報告は1件、死亡報告は確認されていません。主な問題としてはDefective Component（部品の不良）やMaterial Integrity Problem（材料の完全性の問題）が挙げられています。回収については累計件数が0件であり、報告されていません。",{"pma":569,"k510":570,"as_of":572,"events":573,"recalls":576,"top_problems":578},{"latest":45,"originals":44,"supplements":44},{"total":46,"last5y":376,"latest":571,"applicants":329},"2024-01-16","2026-08",{"death":44,"other":44,"total":47,"injury":447,"last5y":447,"malfunction":574,"latest_month":575},17,"2023-08",{"total":44,"last5y":44,"latest":45,"class_i":44,"class_ii":44,"class_iii":44,"top_root_causes":577},[],[579,580],"Defective Component","Material Integrity Problem","39f274e178b1ba056fdbea6ea59f184a6349bf654ecd6ac273f8b6d7d6da775d","2026-08-24T05:07:49.137996+00:00",{"items":584,"total":44},[],{"items":586,"total":46},[587,593,597,601,605,609,614,618,621,625,628],{"k_number":20,"device_name":588,"applicant":589,"decision_date":571,"clearance_type":590,"decision_code":591,"statement_or_summary":592},"Uni-port","Dalim Medical Corp.","Traditional","SESE","Summary",{"k_number":26,"device_name":594,"applicant":595,"decision_date":596,"clearance_type":590,"decision_code":591,"statement_or_summary":592},"CORE-SPORT","Incore Co., Ltd.","2022-09-28",{"k_number":24,"device_name":598,"applicant":599,"decision_date":600,"clearance_type":590,"decision_code":591,"statement_or_summary":592},"AFS Medical Sterile Single-Use Access Port System","Afs Medical Co. , Ltd.","2021-10-14",{"k_number":25,"device_name":602,"applicant":603,"decision_date":604,"clearance_type":590,"decision_code":591,"statement_or_summary":592},"FMX314 Surgical Platform","Fortimedix Surgical B.V.","2016-08-26",{"k_number":21,"device_name":606,"applicant":607,"decision_date":608,"clearance_type":590,"decision_code":591,"statement_or_summary":592},"Endo Keeper","Nelis","2016-03-17",{"k_number":22,"device_name":610,"applicant":611,"decision_date":612,"clearance_type":613,"decision_code":591,"statement_or_summary":592},"ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE","Advanced Surgical Concepts","2012-09-06","Special",{"k_number":23,"device_name":615,"applicant":616,"decision_date":617,"clearance_type":590,"decision_code":591,"statement_or_summary":592},"KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA","Richard Wolf Medical Instruments Corp.","2012-08-03",{"k_number":27,"device_name":619,"applicant":611,"decision_date":620,"clearance_type":590,"decision_code":591,"statement_or_summary":592},"TRIPORT, TRIPORT+, TRIPORT15, QUADPORT","2012-01-18",{"k_number":19,"device_name":622,"applicant":623,"decision_date":624,"clearance_type":613,"decision_code":591,"statement_or_summary":592},"OCTOTMPORT","Dalim Surgnet Corporation","2011-09-14",{"k_number":29,"device_name":626,"applicant":611,"decision_date":627,"clearance_type":613,"decision_code":591,"statement_or_summary":592},"ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE","2011-01-26",{"k_number":28,"device_name":629,"applicant":611,"decision_date":630,"clearance_type":613,"decision_code":591,"statement_or_summary":592},"ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA","2010-11-29",{"items":632,"total":44},[]]