[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GBJ":3},{"classification":4,"mappedDevices":46,"similarCandidates":47,"relatedClassifications":118,"syncDates":119,"translation":126,"marketSummary":132,"recalls":148,"k510s":150,"pmas":170},{"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":40,"updated_at":41,"recall_count":42,"latest_recall_date":43,"k510_count":44,"pma_count":42,"event_count":45},6969,"GBJ","Prosthesis, Adhesive, External","1","878.3750","SU","General, Plastic Surgery","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":38,"product_code":6,"review_panel":10,"gmp_exempt_flag":38,"third_party_flag":38,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":38,"medical_specialty_description":11,"summary_malfunction_reporting":39},{"k_number":17,"fei_number":22,"registration_number":35},[18,19,20,21],"K934970","K810282","K790186","K790946",[13,23,24,25,26,27,28,29,30,31,32,33,34],"3024491894","2023623","2023344","1000641183","3010657142","3012421607","3027269355","3002806269","3011363737","3005855077","3002876349","3023464160",[13,23,24,25,26,27,28,29,36,31,32,37,34],"9617078","8032044","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:48.225237+00:00",0,null,4,3,[],[48,56,64,71,78,84,91,97,104,111],{"medical_device_id":49,"generic_name":50,"class_classification":51,"jmdn_code":52,"name_similarity":53,"definition_similarity":42,"vector_similarity":54,"score":55},670,"耳用補綴材","Ⅲ","35262000",0.4,0.716128,0.0325225,{"medical_device_id":57,"generic_name":58,"class_classification":59,"jmdn_code":60,"name_similarity":61,"definition_similarity":42,"vector_similarity":62,"score":63},4316,"人工装具ドライバ","Ⅰ","32865000",0.363636,0.703743,0.0305504,{"medical_device_id":65,"generic_name":66,"class_classification":51,"jmdn_code":67,"name_similarity":68,"definition_similarity":42,"vector_similarity":69,"score":70},633,"橈骨頭用補綴材","35966003",0.315789,0.710986,0.0273897,{"medical_device_id":72,"generic_name":73,"class_classification":51,"jmdn_code":74,"name_similarity":75,"definition_similarity":42,"vector_similarity":76,"score":77},569,"全人工股関節","36315000",0.333333,0.69913,0.0270715,{"medical_device_id":79,"generic_name":80,"class_classification":51,"jmdn_code":81,"name_similarity":75,"definition_similarity":42,"vector_similarity":82,"score":83},636,"人工指関節","37845000",0.686789,0.0248687,{"medical_device_id":85,"generic_name":86,"class_classification":51,"jmdn_code":87,"name_similarity":88,"definition_similarity":42,"vector_similarity":89,"score":90},572,"全人工膝関節","35667000",0.324324,0.685734,0.0244229,{"medical_device_id":92,"generic_name":93,"class_classification":51,"jmdn_code":94,"name_similarity":68,"definition_similarity":42,"vector_similarity":95,"score":96},620,"全人工手関節","33705000",0.683423,0.0234118,{"medical_device_id":98,"generic_name":99,"class_classification":51,"jmdn_code":100,"name_similarity":101,"definition_similarity":42,"vector_similarity":102,"score":103},615,"全人工足関節","32837000",0.3,0.682588,0.0222222,{"medical_device_id":105,"generic_name":106,"class_classification":51,"jmdn_code":107,"name_similarity":108,"definition_similarity":42,"vector_similarity":109,"score":110},519,"非吸収性ステープルライン補強材料","70435000",0.181818,0.719959,0.0163934,{"medical_device_id":112,"generic_name":113,"class_classification":51,"jmdn_code":114,"name_similarity":115,"definition_similarity":42,"vector_similarity":116,"score":117},664,"人工肛門括約筋補綴材","34092000",0.394737,0.614409,0.016129,[],{"510k":120,"classification":121,"enforcement":122,"event":123,"pma":124,"warning_letter":125},"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":127,"definition_ja":43,"commentary_ja":128,"model_name":129,"source_hash":130,"reviewed_by":43,"reviewed_at":43,"created_at":131,"updated_at":131},"外用接着性補綴具","本品目は米国FDAの規制区分においてクラスIに分類される医療機器です。クラスIは相対的にリスクが低い機器を対象とする区分であり、本品目は市販前届出（510(k)）の対象からも除外される届出免除の扱いとなっています。","claude-sonnet-5","5e5448477047cb44f25876872380e4c68d062d4bf2526bbedc6eec78bcfcaafd","2026-08-24T01:52:15.787179+00:00",{"product_code":6,"summary_ja":133,"stats":134,"stats_hash":146,"model_name":129,"created_at":147,"updated_at":147},"本製品コードでは、510(k)の累計届出件数は4件で、4社が申請していますが、直近5年間の届出はなく、最新の判定は1993年12月となっています。PMAでの承認実績は確認されていません。不具合報告（MDR）は累計3件で、内訳は傷害1件、不具合（Malfunction）2件となっており、直近5年間では2件、最新の報告は2023年12月です。回収（リコール）の実績は確認されていません。",{"pma":135,"k510":136,"as_of":138,"events":139,"recalls":143,"top_problems":145},{"latest":43,"originals":42,"supplements":42},{"total":44,"last5y":42,"latest":137,"applicants":44},"1993-12-10","2026-08",{"death":42,"other":42,"total":45,"injury":140,"last5y":141,"malfunction":141,"latest_month":142},1,2,"2023-12",{"total":42,"last5y":42,"latest":43,"class_i":42,"class_ii":42,"class_iii":42,"top_root_causes":144},[],[],"0991de4308852454b0a86ce7c66301bf1d87d90fed0eb260f7ee66eb2eb7b98f","2026-08-24T04:25:47.269073+00:00",{"items":149,"total":42},[],{"items":151,"total":44},[152,158,162,166],{"k_number":18,"device_name":153,"applicant":154,"decision_date":137,"clearance_type":155,"decision_code":156,"statement_or_summary":157},"DUET","Trulife , Ltd.","Traditional","SESE","Statement",{"k_number":19,"device_name":159,"applicant":160,"decision_date":161,"clearance_type":155,"decision_code":156,"statement_or_summary":43},"OPERATING TABLE ACCESSORY CLAMP","Minnesota Scientific, Inc.","1981-02-26",{"k_number":21,"device_name":163,"applicant":164,"decision_date":165,"clearance_type":155,"decision_code":156,"statement_or_summary":43},"GORDON IVS INTRAVENOUS STABILIZER","Whitman Medical Corp.","1979-06-05",{"k_number":20,"device_name":167,"applicant":168,"decision_date":169,"clearance_type":155,"decision_code":156,"statement_or_summary":43},"PROTECTIVSTABILIZER","Jelco Laboratories","1979-02-26",{"items":171,"total":42},[]]