[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OHG":3},{"classification":4,"mappedDevices":67,"similarCandidates":68,"relatedClassifications":149,"syncDates":284},{"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":61,"updated_at":62,"recall_count":63,"latest_recall_date":64,"k510_count":65,"pma_count":65,"event_count":66},3980,"OHG","Circumcision Tray","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":58,"device_class":8,"implant_flag":59,"product_code":6,"review_panel":10,"gmp_exempt_flag":59,"third_party_flag":59,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":58,"life_sustain_support_flag":59,"medical_specialty_description":11,"summary_malfunction_reporting":60},{"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","3007329020","3005012805","3009888344","1047429","1420054","1000114163","1000514656","3004111573","1643817","3005846326","3000717925","3045816902","1928237","1030451","1824619","3015173212","2433012","3004122598","1000160458","3004513970","1000512168","3001236905","1043214","1000112877","3002902735","3035642068","3005595283","1000120555",[18,48,49,19,20,21,22,23,50,51,26,52,27,53,30,31,32,34,33,54,35,36,38,55,56,41,57,44,45],"1423395","1422634","1054241","1054786","1423537","1223004","1061124","2029015","9616088","3004519921","","N","Eligible","2026-08-18T05:52:51.341121+00:00","2026-08-19T02:30:42.714273+00:00",20,"2026-07-08",0,55,[],[69,78,87,94,102,110,119,126,134,141],{"medical_device_id":70,"generic_name":71,"class_classification":72,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},2266,"単回使用環状切除キット","Ⅱ","34945000",0.393939,0.147849,0.722321,0.0327869,{"medical_device_id":79,"generic_name":80,"class_classification":81,"jmdn_code":82,"name_similarity":83,"definition_similarity":84,"vector_similarity":85,"score":86},4228,"再使用可能な包皮切除術中用クランプ","Ⅰ","10869000",0.317073,0.136667,0.636597,0.0312805,{"medical_device_id":88,"generic_name":89,"class_classification":81,"jmdn_code":90,"name_similarity":83,"definition_similarity":91,"vector_similarity":92,"score":93},4254,"単回使用環状切除術用クランプ","38525000",0.0921502,0.605634,0.027109,{"medical_device_id":95,"generic_name":96,"class_classification":72,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":101},2310,"再使用可能な吸引キット","37447000",0.0540541,0.174419,0.653881,0.016129,{"medical_device_id":103,"generic_name":104,"class_classification":72,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":109},1813,"骨盤検査キット","34122000",0.0512821,0.118694,0.646587,0.015873,{"medical_device_id":111,"generic_name":112,"class_classification":113,"jmdn_code":114,"name_similarity":115,"definition_similarity":116,"vector_similarity":117,"score":118},34,"抗菌作用中心静脈用カテーテルイントロデューサキット","Ⅳ","16615400",0.0655738,0.126984,0.64049,0.015625,{"medical_device_id":120,"generic_name":121,"class_classification":81,"jmdn_code":122,"name_similarity":123,"definition_similarity":124,"vector_similarity":125,"score":118},4017,"歯科印象採得用トレー","16350000",0.242424,0.113793,0.500209,{"medical_device_id":127,"generic_name":128,"class_classification":72,"jmdn_code":129,"name_similarity":130,"definition_similarity":131,"vector_similarity":132,"score":133},2307,"単回使用吸引キット","36142000",0.0526316,0.155779,0.639961,0.0153846,{"medical_device_id":135,"generic_name":136,"class_classification":81,"jmdn_code":137,"name_similarity":138,"definition_similarity":139,"vector_similarity":140,"score":133},4110,"歯科印象トレー用レジン","70832000",0.210526,0.120915,0.53497,{"medical_device_id":142,"generic_name":143,"class_classification":81,"jmdn_code":144,"name_similarity":145,"definition_similarity":146,"vector_similarity":147,"score":148},3259,"X線用テレビ装置","70027000",0.2,0.12285,0.444287,0.0151515,[150,154,158,162,166,170,174,178,183,186,190,193,197,201,205,208,211,214,218,221,225,229,232,235,238,241,245,248,251,254,257,260,263,266,269,272,275,278,281],{"product_code":151,"device_name":152,"device_class":8,"k510_count":153},"LKF","Cannula, Manipulator\u002FInjector, Uterine",87,{"product_code":155,"device_name":156,"device_class":8,"k510_count":157},"HHT","Spatula, Cervical, Cytological",73,{"product_code":159,"device_name":160,"device_class":8,"k510_count":161},"HIB","Speculum, Vaginal, Nonmetal",72,{"product_code":163,"device_name":164,"device_class":8,"k510_count":165},"KNA","Instrument, Manual, Specialized Obstetric-Gynecologic",58,{"product_code":167,"device_name":168,"device_class":8,"k510_count":169},"HFW","Clamp, Umbilical",36,{"product_code":171,"device_name":172,"device_class":8,"k510_count":173},"HFX","Clamp, Circumcision",27,{"product_code":175,"device_name":176,"device_class":8,"k510_count":177},"HCZ","Forceps, Surgical, Gynecological",24,{"product_code":179,"device_name":180,"device_class":181,"k510_count":182},"HFB","Forceps, Biopsy, Gynecological","1",22,{"product_code":184,"device_name":185,"device_class":8,"k510_count":63},"HDC","Tenaculum, Uterine",{"product_code":187,"device_name":188,"device_class":181,"k510_count":189},"HCY","Curette, Uterine",11,{"product_code":191,"device_name":192,"device_class":8,"k510_count":189},"OQY","Intrauterine Tamponade Balloon",{"product_code":194,"device_name":195,"device_class":181,"k510_count":196},"HHM","Sound, Uterine",10,{"product_code":198,"device_name":199,"device_class":8,"k510_count":200},"PBQ","Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use",8,{"product_code":202,"device_name":203,"device_class":181,"k510_count":204},"HDQ","Dilator, Cervical, Fixed Size",6,{"product_code":206,"device_name":207,"device_class":181,"k510_count":204},"HGE","Amniotome",{"product_code":209,"device_name":210,"device_class":181,"k510_count":204},"HHF","Remover, Intrauterine Device, Contraceptive, Hook-Type",{"product_code":212,"device_name":213,"device_class":8,"k510_count":204},"MLS","Labor And Delivery Kit",{"product_code":215,"device_name":216,"device_class":8,"k510_count":217},"HIC","Speculum, Vaginal, Nonmetal, Fiberoptic",5,{"product_code":219,"device_name":220,"device_class":8,"k510_count":217},"MOV","Catheters, Salpingography",{"product_code":222,"device_name":223,"device_class":8,"k510_count":224},"HDP","Elevator, Uterine",4,{"product_code":226,"device_name":227,"device_class":8,"k510_count":228},"FHG","Bell, Circumcision",2,{"product_code":230,"device_name":231,"device_class":8,"k510_count":228},"FHJ","Shield, Circumcision",{"product_code":233,"device_name":234,"device_class":8,"k510_count":228},"HHO","Screw, Fibroid, Gynecological",{"product_code":236,"device_name":237,"device_class":8,"k510_count":228},"MPU","Source, Chemiluminescent Light",{"product_code":239,"device_name":240,"device_class":8,"k510_count":228},"PGK","Cannula, Injector, Uterine, Endometrial Biopsy",{"product_code":242,"device_name":243,"device_class":8,"k510_count":244},"LBX","Pelvimeter, Internal",1,{"product_code":246,"device_name":247,"device_class":8,"k510_count":244},"MDG","System, Intrafallopian Cannula",{"product_code":249,"device_name":250,"device_class":8,"k510_count":244},"MLT","Pelvic Exam Kit",{"product_code":252,"device_name":253,"device_class":8,"k510_count":244},"NBZ","Clamp And Cutter, Umbilical",{"product_code":255,"device_name":256,"device_class":181,"k510_count":65},"HDH","Needle, Cerclage, Gynecological",{"product_code":258,"device_name":259,"device_class":8,"k510_count":65},"HDZ","Knife, Cervical Cone",{"product_code":261,"device_name":262,"device_class":8,"k510_count":65},"NMG","Forceps, Biopsy, Gynecological, Reprocessed",{"product_code":264,"device_name":265,"device_class":8,"k510_count":65},"OHL","Pap Smear Kit",{"product_code":267,"device_name":268,"device_class":8,"k510_count":65},"OJF","Hysterectomy Kit",{"product_code":270,"device_name":271,"device_class":8,"k510_count":65},"OKY","Cytology Kit",{"product_code":273,"device_name":274,"device_class":8,"k510_count":65},"PUA","Tenaculum, Uterine, Exempt",{"product_code":276,"device_name":277,"device_class":8,"k510_count":65},"PVR","D&C Tray",{"product_code":279,"device_name":280,"device_class":8,"k510_count":65},"PVX","Vaginal Examination Tray",{"product_code":282,"device_name":283,"device_class":8,"k510_count":65},"QQR","Circumcision Device With Stapler",{"510k":285,"classification":286,"enforcement":287,"event":288,"pma":289,"warning_letter":290},"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"]