[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OHD":3},{"classification":4,"mappedDevices":65,"similarCandidates":66,"relatedClassifications":147,"syncDates":168},{"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":59,"updated_at":60,"recall_count":61,"latest_recall_date":62,"k510_count":63,"pma_count":63,"event_count":64},909,"OHD","Gynecological Laparoscopic Kit","2","884.1720","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":56,"device_class":8,"implant_flag":57,"product_code":6,"review_panel":10,"gmp_exempt_flag":57,"third_party_flag":57,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":56,"life_sustain_support_flag":57,"medical_specialty_description":11,"summary_malfunction_reporting":58},{"fei_number":17,"registration_number":47},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"3045816907","1000121056","3007329020","3004911384","3005012805","3009888344","3014925393","1047429","3004111573","1643817","3003040625","3005099803","3000717925","3045816902","1928237","1030451","3015173212","3004122598","1000160458","1000512168","3001236905","1043214","1000112877","2124215","3002902735","1000112968","3035642068","3005595283","3004859928",[18,48,19,49,20,21,22,23,24,25,50,51,26,52,27,29,31,32,33,34,53,35,54,55,39,41,44,45,46],"1423395","1055236","2320762","1054241","1423537","1061124","2029015","9616088","","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-18T22:05:38.961415+00:00",52,"2026-07-29",0,328,[],[67,76,85,93,101,108,117,124,132,139],{"medical_device_id":68,"generic_name":69,"class_classification":70,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},1736,"腹腔鏡キット","Ⅱ","32043000",0.424242,0.186589,0.679813,0.0327869,{"medical_device_id":77,"generic_name":78,"class_classification":79,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},3871,"婦人科用手術台","Ⅰ","36618000",0.24,0.0483271,0.609053,0.0268468,{"medical_device_id":86,"generic_name":87,"class_classification":70,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},1721,"腎盂鏡検査キット","32083000",0.179487,0.184211,0.602948,0.0237093,{"medical_device_id":94,"generic_name":95,"class_classification":70,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":100},1813,"骨盤検査キット","34122000",0.102041,0.118694,0.642475,0.016129,{"medical_device_id":102,"generic_name":103,"class_classification":79,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":100},3448,"腹腔鏡用へら","36083000",0.333333,0.135484,0.55793,{"medical_device_id":109,"generic_name":110,"class_classification":111,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":116},191,"単回使用クラスⅣ処置キット","Ⅳ","33961004",0.123077,0.161994,0.632688,0.015873,{"medical_device_id":118,"generic_name":119,"class_classification":79,"jmdn_code":120,"name_similarity":121,"definition_similarity":122,"vector_similarity":123,"score":116},4299,"婦人科用剥離子","70955000",0.272727,0.0935484,0.553447,{"medical_device_id":125,"generic_name":126,"class_classification":70,"jmdn_code":127,"name_similarity":128,"definition_similarity":129,"vector_similarity":130,"score":131},1730,"硬性腹腔鏡","12291000",0.25641,0.173302,0.559155,0.015625,{"medical_device_id":133,"generic_name":134,"class_classification":70,"jmdn_code":135,"name_similarity":136,"definition_similarity":137,"vector_similarity":138,"score":131},1870,"子宮内組織採取キット","11531000",0.0980392,0.159892,0.627509,{"medical_device_id":140,"generic_name":141,"class_classification":70,"jmdn_code":142,"name_similarity":143,"definition_similarity":144,"vector_similarity":145,"score":146},1889,"単回使用羊水穿刺キット","35496000",0.0714286,0.143266,0.626218,0.0153846,[148,152,155,159,162,165],{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"HET","Laparoscope, Gynecologic (And Accessories)",338,{"product_code":153,"device_name":154,"device_class":8,"k510_count":63},"NMH","Laparoscope And Accessories, Gynecologic, Reprocessed",{"product_code":156,"device_name":157,"device_class":158,"k510_count":63},"NWV","Laparoscopic Accessories, Gynecologic","1",{"product_code":160,"device_name":161,"device_class":8,"k510_count":63},"OCQ","Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence",{"product_code":163,"device_name":164,"device_class":8,"k510_count":63},"OHM","Cesarean Section Tray",{"product_code":166,"device_name":167,"device_class":8,"k510_count":63},"OKX","Trocar Kit",{"510k":169,"classification":170,"enforcement":171,"event":172,"pma":173,"warning_letter":174},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]