[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-ETC":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":108,"syncDates":109,"translation":116,"marketSummary":122,"recalls":135,"k510s":137,"pmas":145},{"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":15,"gmp_exempt_flag":15,"raw":16,"created_at":29,"updated_at":30,"recall_count":31,"latest_recall_date":32,"k510_count":33,"pma_count":31,"event_count":31},552,"ETC","Mold, Middle-Ear","2","874.3430","EN","Ear, Nose, Throat","4","",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":26,"product_code":6,"review_panel":10,"gmp_exempt_flag":27,"third_party_flag":27,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":27,"medical_specialty_description":11,"summary_malfunction_reporting":28},{"k_number":18,"fei_number":20,"registration_number":25},[19],"K921433",[21,22,23,24],"1037007","1928237","3011050570","3003790304",[21,22,23,24],"Y","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-24T02:00:48.493322+00:00",0,null,1,[],[36,44,51,59,67,74,81,88,94,101],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":31,"vector_similarity":42,"score":43},656,"中耳用植込みモールド","Ⅲ","31934000",0.576923,0.791995,0.0327869,{"medical_device_id":45,"generic_name":46,"class_classification":39,"jmdn_code":47,"name_similarity":48,"definition_similarity":31,"vector_similarity":49,"score":50},839,"人工中耳","30084000",0.323529,0.646919,0.032002,{"medical_device_id":52,"generic_name":53,"class_classification":54,"jmdn_code":55,"name_similarity":56,"definition_similarity":31,"vector_similarity":57,"score":58},2971,"モジュラ式耳あな型補聴器","Ⅱ","41193000",0.157895,0.607735,0.0298774,{"medical_device_id":60,"generic_name":61,"class_classification":62,"jmdn_code":63,"name_similarity":64,"definition_similarity":31,"vector_similarity":65,"score":66},3839,"再使用可能な耳科用カテーテル","Ⅰ","33395000",0.15625,0.594858,0.0290404,{"medical_device_id":68,"generic_name":69,"class_classification":62,"jmdn_code":70,"name_similarity":71,"definition_similarity":31,"vector_similarity":72,"score":73},4170,"耳用ナイフ","12245000",0.190476,0.579649,0.0286935,{"medical_device_id":75,"generic_name":76,"class_classification":54,"jmdn_code":77,"name_similarity":78,"definition_similarity":31,"vector_similarity":79,"score":80},2968,"耳かけ型補聴器","34671000",0.108108,0.636621,0.0272529,{"medical_device_id":82,"generic_name":83,"class_classification":54,"jmdn_code":84,"name_similarity":85,"definition_similarity":31,"vector_similarity":86,"score":87},2970,"耳あな型補聴器","34672000",0.121212,0.607021,0.026905,{"medical_device_id":89,"generic_name":90,"class_classification":62,"jmdn_code":91,"name_similarity":71,"definition_similarity":31,"vector_similarity":92,"score":93},3907,"耳照明器","41238000",0.563922,0.026861,{"medical_device_id":95,"generic_name":96,"class_classification":54,"jmdn_code":97,"name_similarity":98,"definition_similarity":31,"vector_similarity":99,"score":100},1762,"硬性耳内視鏡","70153000",0.133333,0.584041,0.0266667,{"medical_device_id":102,"generic_name":103,"class_classification":62,"jmdn_code":104,"name_similarity":105,"definition_similarity":31,"vector_similarity":106,"score":107},4135,"歯科用ワックス成形品","31836020",0.137931,0.569612,0.0257468,[],{"510k":110,"classification":111,"enforcement":112,"event":113,"pma":114,"warning_letter":115},"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":117,"definition_ja":32,"commentary_ja":118,"model_name":119,"source_hash":120,"reviewed_by":32,"reviewed_at":32,"created_at":121,"updated_at":121},"中耳形成用モールド","本機器は米国FDAの規制上、クラスIIに分類される医療機器です。クラスIIは中程度のリスクを有する機器区分ですが、本品は510(k)による市販前届出が免除されており、通常のクラスII機器に求められる届出手続きなしに市販が可能とされています。","claude-sonnet-5","16ed9796c1b46ee9338e3bc86a0efa7a0ea0ca3441078eefe7fc0dd0226a905f","2026-08-24T01:50:05.227637+00:00",{"product_code":6,"summary_ja":123,"stats":124,"stats_hash":133,"model_name":119,"created_at":134,"updated_at":134},"本製品コードでは、510(k)の累計件数は1件、参入企業数は1社で、直近5年間の届出はありません。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、確認されていません。",{"pma":125,"k510":126,"as_of":128,"events":129,"recalls":130,"top_problems":132},{"latest":32,"originals":31,"supplements":31},{"total":33,"last5y":31,"latest":127,"applicants":33},"1993-03-18","2026-08",{"death":31,"other":31,"total":31,"injury":31,"last5y":31,"malfunction":31,"latest_month":32},{"total":31,"last5y":31,"latest":32,"class_i":31,"class_ii":31,"class_iii":31,"top_root_causes":131},[],[],"eed4392ed5234d85d11adf85251af18fcacd8290fc94b19aac1bfaf2ef47c0af","2026-08-24T04:18:34.328284+00:00",{"items":136,"total":31},[],{"items":138,"total":33},[139],{"k_number":19,"device_name":140,"applicant":141,"decision_date":127,"clearance_type":142,"decision_code":143,"statement_or_summary":144},"ATTIC DEFECT PLATE","Smith & Nephew Richards, Inc.","Traditional","SESE","Summary",{"items":146,"total":31},[]]