[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FHJ":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":100,"syncDates":234,"translation":241,"marketSummary":247,"recalls":260,"k510s":262,"pmas":273},{"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":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":26,"pma_count":24,"event_count":24},5534,"FHJ","Shield, Circumcision","2","884.4530","OB","Obstetrics\u002FGynecology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":10,"gmp_exempt_flag":20,"third_party_flag":20,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":20,"medical_specialty_description":11,"summary_malfunction_reporting":21},{"k_number":17},[18,19],"K831229","K902119","N","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-24T02:00:48.095002+00:00",0,null,2,[],[29,37,45,52,58,65,73,80,87,93],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":24,"vector_similarity":35,"score":36},2266,"単回使用環状切除キット","Ⅱ","34945000",0.411765,0.70125,0.0327869,{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":24,"vector_similarity":43,"score":44},4228,"再使用可能な包皮切除術中用クランプ","Ⅰ","10869000",0.333333,0.670496,0.031746,{"medical_device_id":46,"generic_name":47,"class_classification":40,"jmdn_code":48,"name_similarity":49,"definition_similarity":24,"vector_similarity":50,"score":51},3801,"腱膜瘤防護具","13565000",0.36,0.655237,0.0315136,{"medical_device_id":53,"generic_name":54,"class_classification":40,"jmdn_code":55,"name_similarity":42,"definition_similarity":24,"vector_similarity":56,"score":57},4254,"単回使用環状切除術用クランプ","38525000",0.635021,0.0303309,{"medical_device_id":59,"generic_name":60,"class_classification":32,"jmdn_code":61,"name_similarity":62,"definition_similarity":24,"vector_similarity":63,"score":64},2986,"男性向け避妊用コンドーム","36282000",0.0238095,0.689948,0.016129,{"medical_device_id":66,"generic_name":67,"class_classification":68,"jmdn_code":69,"name_similarity":70,"definition_similarity":24,"vector_similarity":71,"score":72},183,"癒着防止吸収性バリア","Ⅳ","34212000",0.0555556,0.659706,0.015625,{"medical_device_id":74,"generic_name":75,"class_classification":32,"jmdn_code":76,"name_similarity":77,"definition_similarity":24,"vector_similarity":78,"score":79},2410,"呼吸回路セット","70566000",0.166667,0.416064,0.0153846,{"medical_device_id":81,"generic_name":82,"class_classification":32,"jmdn_code":83,"name_similarity":84,"definition_similarity":24,"vector_similarity":85,"score":86},2272,"植皮用皮膚剥離器","70449000",0.025,0.645472,0.0151515,{"medical_device_id":88,"generic_name":89,"class_classification":32,"jmdn_code":90,"name_similarity":91,"definition_similarity":24,"vector_similarity":92,"score":86},2394,"遠心型血液浄化装置用回路","70556000",0.150943,0.45458,{"medical_device_id":94,"generic_name":95,"class_classification":68,"jmdn_code":96,"name_similarity":97,"definition_similarity":24,"vector_similarity":98,"score":99},106,"中心循環系閉塞術用血管内カテーテル","32584004",0.147541,0.538723,0.0149254,[101,105,109,113,117,121,125,129,133,137,141,144,148,152,156,159,162,165,169,172,176,179,182,185,188,192,195,198,201,204,207,210,213,216,219,222,225,228,231],{"product_code":102,"device_name":103,"device_class":8,"k510_count":104},"LKF","Cannula, Manipulator\u002FInjector, Uterine",87,{"product_code":106,"device_name":107,"device_class":8,"k510_count":108},"HHT","Spatula, Cervical, Cytological",73,{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"HIB","Speculum, Vaginal, Nonmetal",72,{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"KNA","Instrument, Manual, Specialized Obstetric-Gynecologic",58,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"HFW","Clamp, Umbilical",36,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"HFX","Clamp, Circumcision",27,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"HCZ","Forceps, Surgical, Gynecological",24,{"product_code":130,"device_name":131,"device_class":12,"k510_count":132},"HFB","Forceps, Biopsy, Gynecological",22,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"HDC","Tenaculum, Uterine",20,{"product_code":138,"device_name":139,"device_class":12,"k510_count":140},"HCY","Curette, Uterine",11,{"product_code":142,"device_name":143,"device_class":8,"k510_count":140},"OQY","Intrauterine Tamponade Balloon",{"product_code":145,"device_name":146,"device_class":12,"k510_count":147},"HHM","Sound, Uterine",10,{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"PBQ","Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use",8,{"product_code":153,"device_name":154,"device_class":12,"k510_count":155},"HDQ","Dilator, Cervical, Fixed Size",6,{"product_code":157,"device_name":158,"device_class":12,"k510_count":155},"HGE","Amniotome",{"product_code":160,"device_name":161,"device_class":12,"k510_count":155},"HHF","Remover, Intrauterine Device, Contraceptive, Hook-Type",{"product_code":163,"device_name":164,"device_class":8,"k510_count":155},"MLS","Labor And Delivery Kit",{"product_code":166,"device_name":167,"device_class":8,"k510_count":168},"HIC","Speculum, Vaginal, Nonmetal, Fiberoptic",5,{"product_code":170,"device_name":171,"device_class":8,"k510_count":168},"MOV","Catheters, Salpingography",{"product_code":173,"device_name":174,"device_class":8,"k510_count":175},"HDP","Elevator, Uterine",4,{"product_code":177,"device_name":178,"device_class":8,"k510_count":26},"FHG","Bell, Circumcision",{"product_code":180,"device_name":181,"device_class":8,"k510_count":26},"HHO","Screw, Fibroid, Gynecological",{"product_code":183,"device_name":184,"device_class":8,"k510_count":26},"MPU","Source, Chemiluminescent Light",{"product_code":186,"device_name":187,"device_class":8,"k510_count":26},"PGK","Cannula, Injector, Uterine, Endometrial Biopsy",{"product_code":189,"device_name":190,"device_class":8,"k510_count":191},"LBX","Pelvimeter, Internal",1,{"product_code":193,"device_name":194,"device_class":8,"k510_count":191},"MDG","System, Intrafallopian Cannula",{"product_code":196,"device_name":197,"device_class":8,"k510_count":191},"MLT","Pelvic Exam Kit",{"product_code":199,"device_name":200,"device_class":8,"k510_count":191},"NBZ","Clamp And Cutter, Umbilical",{"product_code":202,"device_name":203,"device_class":12,"k510_count":24},"HDH","Needle, Cerclage, Gynecological",{"product_code":205,"device_name":206,"device_class":8,"k510_count":24},"HDZ","Knife, Cervical Cone",{"product_code":208,"device_name":209,"device_class":8,"k510_count":24},"NMG","Forceps, Biopsy, Gynecological, Reprocessed",{"product_code":211,"device_name":212,"device_class":8,"k510_count":24},"OHG","Circumcision Tray",{"product_code":214,"device_name":215,"device_class":8,"k510_count":24},"OHL","Pap Smear Kit",{"product_code":217,"device_name":218,"device_class":8,"k510_count":24},"OJF","Hysterectomy Kit",{"product_code":220,"device_name":221,"device_class":8,"k510_count":24},"OKY","Cytology Kit",{"product_code":223,"device_name":224,"device_class":8,"k510_count":24},"PUA","Tenaculum, Uterine, Exempt",{"product_code":226,"device_name":227,"device_class":8,"k510_count":24},"PVR","D&C Tray",{"product_code":229,"device_name":230,"device_class":8,"k510_count":24},"PVX","Vaginal Examination Tray",{"product_code":232,"device_name":233,"device_class":8,"k510_count":24},"QQR","Circumcision Device With Stapler",{"510k":235,"classification":236,"enforcement":237,"event":238,"pma":239,"warning_letter":240},"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":242,"definition_ja":25,"commentary_ja":243,"model_name":244,"source_hash":245,"reviewed_by":25,"reviewed_at":25,"created_at":246,"updated_at":246},"包皮切除保護具","本品は割礼（包皮切除術）の施術時に使用される保護器具です。米国ではクラスIIに分類されており、市販前届出（510(k)）による審査を経て、既存の同等品との実質的同等性が確認されれば市販が認められます。","claude-sonnet-5","bc064d1d49e3acac42b4672f6167fefe3cbb096b820563fe2659b5ef57aa51c3","2026-08-24T01:51:19.839721+00:00",{"product_code":6,"summary_ja":248,"stats":249,"stats_hash":258,"model_name":244,"created_at":259,"updated_at":259},"510(k)の累計届出件数は2件で、参入企業数は2社となっていますが、直近5年間の届出実績は確認されていません。不具合報告および回収については、いずれも累計件数が0件であり、報告・実施の事例は確認されていません。",{"pma":250,"k510":251,"as_of":253,"events":254,"recalls":255,"top_problems":257},{"latest":25,"originals":24,"supplements":24},{"total":26,"last5y":24,"latest":252,"applicants":26},"1990-11-05","2026-08",{"death":24,"other":24,"total":24,"injury":24,"last5y":24,"malfunction":24,"latest_month":25},{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":256},[],[],"72b1141fd54c3ac92a9722c205d95048cdecf08adb150c7a8286b25da7f9577a","2026-08-24T04:21:40.396908+00:00",{"items":261,"total":24},[],{"items":263,"total":26},[264,269],{"k_number":19,"device_name":265,"applicant":266,"decision_date":252,"clearance_type":267,"decision_code":268,"statement_or_summary":25},"SAFEBRIS STERILE CIRCUMCISION KIT","Kedumin Kits, Ltd.","Traditional","SESE",{"k_number":18,"device_name":270,"applicant":271,"decision_date":272,"clearance_type":267,"decision_code":268,"statement_or_summary":25},"SUPER SNAPS","Shofu Dental Corp.","1983-05-09",{"items":274,"total":24},[]]