[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OJF":3},{"classification":4,"mappedDevices":58,"similarCandidates":59,"relatedClassifications":139,"syncDates":274},{"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":52,"updated_at":53,"recall_count":54,"latest_recall_date":55,"k510_count":56,"pma_count":56,"event_count":57},3499,"OJF","Hysterectomy Kit","2","884.4530","OB","Obstetrics\u002FGynecology","7","This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov\u002Fcdrh\u002Fode\u002Fconvkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":49,"device_class":8,"implant_flag":50,"product_code":6,"review_panel":10,"gmp_exempt_flag":50,"third_party_flag":50,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":49,"life_sustain_support_flag":50,"medical_specialty_description":11,"summary_malfunction_reporting":51},{"fei_number":17,"registration_number":40},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"1000220280","3007329020","3005012805","3009888344","1047429","3004111573","1643817","3000717925","3045816902","1928237","1030451","3015173212","3004122598","1000160458","1000512168","3001236905","1043214","1000112877","3002902735","1000112968","3035642068","3005595283",[41,42,19,20,21,22,43,23,44,24,26,27,28,29,45,30,46,47,48,34,38,39],"1423395","1055236","1054241","1423537","1061124","1422598","2029015","9616088","","N","Eligible","2026-08-18T05:52:50.955415+00:00","2026-08-18T22:05:38.961415+00:00",25,"2026-06-24",0,8,[],[60,69,78,86,94,103,110,118,125,132],{"medical_device_id":61,"generic_name":62,"class_classification":63,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":68},3650,"ストーマ用洗浄キット","Ⅰ","37716000",0.21875,0.161491,0.619826,0.0288981,{"medical_device_id":70,"generic_name":71,"class_classification":72,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},1960,"輪状甲状膜切開キット","Ⅱ","15028000",0.241379,0.164671,0.617343,0.0282832,{"medical_device_id":79,"generic_name":80,"class_classification":72,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":85},1736,"腹腔鏡キット","32043000",0.137931,0.186589,0.63071,0.026289,{"medical_device_id":87,"generic_name":88,"class_classification":72,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":93},1721,"腎盂鏡検査キット","32083000",0.142857,0.184211,0.608448,0.0227302,{"medical_device_id":95,"generic_name":96,"class_classification":97,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":102},191,"単回使用クラスⅣ処置キット","Ⅳ","33961004",0.0727273,0.161994,0.646143,0.0163934,{"medical_device_id":104,"generic_name":105,"class_classification":72,"jmdn_code":106,"name_similarity":107,"definition_similarity":108,"vector_similarity":109,"score":102},2166,"動脈切開キット","18026000",0.32,0.121795,0.567245,{"medical_device_id":111,"generic_name":112,"class_classification":72,"jmdn_code":113,"name_similarity":114,"definition_similarity":115,"vector_similarity":116,"score":117},1870,"子宮内組織採取キット","11531000",0.105263,0.159892,0.644174,0.016129,{"medical_device_id":119,"generic_name":120,"class_classification":72,"jmdn_code":121,"name_similarity":122,"definition_similarity":123,"vector_similarity":124,"score":117},2561,"硝子体切除ユニット","14386000",0.269231,0.168421,0.510918,{"medical_device_id":126,"generic_name":127,"class_classification":72,"jmdn_code":128,"name_similarity":122,"definition_similarity":129,"vector_similarity":130,"score":131},1961,"気管切開キット","35403000",0.125,0.580029,0.015873,{"medical_device_id":133,"generic_name":134,"class_classification":63,"jmdn_code":135,"name_similarity":136,"definition_similarity":137,"vector_similarity":138,"score":131},3822,"単回使用クラスⅠ処置キット","33961001",0.0740741,0.166154,0.640284,[140,144,148,152,156,160,164,168,173,177,181,184,188,191,195,198,201,204,208,211,215,219,222,225,228,231,235,238,241,244,247,250,253,256,259,262,265,268,271],{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"LKF","Cannula, Manipulator\u002FInjector, Uterine",87,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"HHT","Spatula, Cervical, Cytological",73,{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"HIB","Speculum, Vaginal, Nonmetal",72,{"product_code":153,"device_name":154,"device_class":8,"k510_count":155},"KNA","Instrument, Manual, Specialized Obstetric-Gynecologic",58,{"product_code":157,"device_name":158,"device_class":8,"k510_count":159},"HFW","Clamp, Umbilical",36,{"product_code":161,"device_name":162,"device_class":8,"k510_count":163},"HFX","Clamp, Circumcision",27,{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"HCZ","Forceps, Surgical, Gynecological",24,{"product_code":169,"device_name":170,"device_class":171,"k510_count":172},"HFB","Forceps, Biopsy, Gynecological","1",22,{"product_code":174,"device_name":175,"device_class":8,"k510_count":176},"HDC","Tenaculum, Uterine",20,{"product_code":178,"device_name":179,"device_class":171,"k510_count":180},"HCY","Curette, Uterine",11,{"product_code":182,"device_name":183,"device_class":8,"k510_count":180},"OQY","Intrauterine Tamponade Balloon",{"product_code":185,"device_name":186,"device_class":171,"k510_count":187},"HHM","Sound, Uterine",10,{"product_code":189,"device_name":190,"device_class":8,"k510_count":57},"PBQ","Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use",{"product_code":192,"device_name":193,"device_class":171,"k510_count":194},"HDQ","Dilator, Cervical, Fixed Size",6,{"product_code":196,"device_name":197,"device_class":171,"k510_count":194},"HGE","Amniotome",{"product_code":199,"device_name":200,"device_class":171,"k510_count":194},"HHF","Remover, Intrauterine Device, Contraceptive, Hook-Type",{"product_code":202,"device_name":203,"device_class":8,"k510_count":194},"MLS","Labor And Delivery Kit",{"product_code":205,"device_name":206,"device_class":8,"k510_count":207},"HIC","Speculum, Vaginal, Nonmetal, Fiberoptic",5,{"product_code":209,"device_name":210,"device_class":8,"k510_count":207},"MOV","Catheters, Salpingography",{"product_code":212,"device_name":213,"device_class":8,"k510_count":214},"HDP","Elevator, Uterine",4,{"product_code":216,"device_name":217,"device_class":8,"k510_count":218},"FHG","Bell, Circumcision",2,{"product_code":220,"device_name":221,"device_class":8,"k510_count":218},"FHJ","Shield, Circumcision",{"product_code":223,"device_name":224,"device_class":8,"k510_count":218},"HHO","Screw, Fibroid, Gynecological",{"product_code":226,"device_name":227,"device_class":8,"k510_count":218},"MPU","Source, Chemiluminescent Light",{"product_code":229,"device_name":230,"device_class":8,"k510_count":218},"PGK","Cannula, Injector, Uterine, Endometrial Biopsy",{"product_code":232,"device_name":233,"device_class":8,"k510_count":234},"LBX","Pelvimeter, Internal",1,{"product_code":236,"device_name":237,"device_class":8,"k510_count":234},"MDG","System, Intrafallopian Cannula",{"product_code":239,"device_name":240,"device_class":8,"k510_count":234},"MLT","Pelvic Exam Kit",{"product_code":242,"device_name":243,"device_class":8,"k510_count":234},"NBZ","Clamp And Cutter, Umbilical",{"product_code":245,"device_name":246,"device_class":171,"k510_count":56},"HDH","Needle, Cerclage, Gynecological",{"product_code":248,"device_name":249,"device_class":8,"k510_count":56},"HDZ","Knife, Cervical Cone",{"product_code":251,"device_name":252,"device_class":8,"k510_count":56},"NMG","Forceps, Biopsy, Gynecological, Reprocessed",{"product_code":254,"device_name":255,"device_class":8,"k510_count":56},"OHG","Circumcision Tray",{"product_code":257,"device_name":258,"device_class":8,"k510_count":56},"OHL","Pap Smear Kit",{"product_code":260,"device_name":261,"device_class":8,"k510_count":56},"OKY","Cytology Kit",{"product_code":263,"device_name":264,"device_class":8,"k510_count":56},"PUA","Tenaculum, Uterine, Exempt",{"product_code":266,"device_name":267,"device_class":8,"k510_count":56},"PVR","D&C Tray",{"product_code":269,"device_name":270,"device_class":8,"k510_count":56},"PVX","Vaginal Examination Tray",{"product_code":272,"device_name":273,"device_class":8,"k510_count":56},"QQR","Circumcision Device With Stapler",{"510k":275,"classification":276,"enforcement":277,"event":278,"pma":279,"warning_letter":280},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]