[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HAD":3},{"classification":4,"mappedDevices":36,"similarCandidates":37,"relatedClassifications":108,"syncDates":109,"translation":116,"marketSummary":122,"recalls":141,"k510s":143,"pmas":159},{"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":30,"updated_at":31,"recall_count":32,"latest_recall_date":33,"k510_count":34,"pma_count":32,"event_count":35},1979,"HAD","Rongeur, Powered","2","882.4845","NE","Neurology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":27,"product_code":6,"review_panel":10,"gmp_exempt_flag":27,"third_party_flag":28,"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":29},{"k_number":17,"fei_number":21,"registration_number":25},[18,19,20],"K062413","K022907","K911637",[22,23,24],"3008711893","3002806315","2916714",[26,22,24],"9610612","N","Y","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-24T02:00:47.513022+00:00",0,null,3,43,[],[38,46,54,61,68,75,82,88,95,102],{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":32,"vector_similarity":44,"score":45},3843,"電動式生体用洗浄器","Ⅰ","34628000",0.347826,0.588267,0.0322665,{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":32,"vector_similarity":52,"score":53},2836,"電動式ケラトーム","Ⅱ","12222002",0.32,0.575654,0.0312576,{"medical_device_id":55,"generic_name":56,"class_classification":41,"jmdn_code":57,"name_similarity":58,"definition_similarity":32,"vector_similarity":59,"score":60},3441,"膀胱鏡用骨鉗子","32015000",0.285714,0.714504,0.0306792,{"medical_device_id":62,"generic_name":63,"class_classification":49,"jmdn_code":64,"name_similarity":65,"definition_similarity":32,"vector_similarity":66,"score":67},2857,"電動式角膜バー","32812000",0.333333,0.561715,0.0298277,{"medical_device_id":69,"generic_name":70,"class_classification":49,"jmdn_code":71,"name_similarity":72,"definition_similarity":32,"vector_similarity":73,"score":74},2278,"電動式吸引器","36777000",0.275862,0.583994,0.0293236,{"medical_device_id":76,"generic_name":77,"class_classification":49,"jmdn_code":78,"name_similarity":79,"definition_similarity":32,"vector_similarity":80,"score":81},2555,"電動式植皮刀","11179000",0.307692,0.561571,0.0289583,{"medical_device_id":83,"generic_name":84,"class_classification":49,"jmdn_code":85,"name_similarity":58,"definition_similarity":32,"vector_similarity":86,"score":87},2291,"電動式吸引用ポンプ","36616040",0.573214,0.0288143,{"medical_device_id":89,"generic_name":90,"class_classification":41,"jmdn_code":91,"name_similarity":92,"definition_similarity":32,"vector_similarity":93,"score":94},3868,"電動式ピンチバルブ","70467000",0.296296,0.559029,0.027972,{"medical_device_id":96,"generic_name":97,"class_classification":41,"jmdn_code":98,"name_similarity":99,"definition_similarity":32,"vector_similarity":100,"score":101},3335,"電動式胸部打診つち","35235000",0.258065,0.563393,0.0265845,{"medical_device_id":103,"generic_name":104,"class_classification":49,"jmdn_code":105,"name_similarity":58,"definition_similarity":32,"vector_similarity":106,"score":107},2577,"電動式歯科用ファイル","31878022",0.548323,0.0257287,[],{"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":33,"commentary_ja":118,"model_name":119,"source_hash":120,"reviewed_by":33,"reviewed_at":33,"created_at":121,"updated_at":121},"パワー式ロンジュール","この機器は米国FDAの分類においてクラスIIに該当し、市販前届出（510(k)）による審査区分が適用されます。クラスIIは中程度のリスクを有する医療機器に分類され、一般的にはクラスIIIのように市販前承認（PMA）を要する厳格な審査ではなく、既存の同等品との実質的同等性を示すことで市販が可能となる510(k)手続きが用いられます。","claude-sonnet-5","4b69864fd97ec6be4c5c55019c1bee2e17b7e9897128cf7a26cae773801417e7","2026-08-24T01:55:21.85667+00:00",{"product_code":6,"summary_ja":123,"stats":124,"stats_hash":139,"model_name":119,"created_at":140,"updated_at":140},"510(k)の累計届出件数は3件で、参入企業数は3社、直近5年間の届出は確認されていません。不具合報告は累計約40件で、大半がMalfunction（不具合）で占められており、死亡報告は0件、傷害は6件となっています。主な問題としてはMaterial Fragmentation（材料の破断・破片化）が挙げられています。回収については累計件数0件で、報告は確認されていません。",{"pma":125,"k510":126,"as_of":128,"events":129,"recalls":135,"top_problems":137},{"latest":33,"originals":32,"supplements":32},{"total":34,"last5y":32,"latest":127,"applicants":34},"2006-11-21","2026-08",{"death":32,"other":130,"total":35,"injury":131,"last5y":132,"malfunction":133,"latest_month":134},2,6,1,35,"2022-07",{"total":32,"last5y":32,"latest":33,"class_i":32,"class_ii":32,"class_iii":32,"top_root_causes":136},[],[138],"Material Fragmentation","eff6d38d53694ddffc20b6c283cc42aaed6a275865e1ed961a161d80124bf728","2026-08-24T04:30:57.116764+00:00",{"items":142,"total":32},[],{"items":144,"total":34},[145,151,155],{"k_number":18,"device_name":146,"applicant":147,"decision_date":127,"clearance_type":148,"decision_code":149,"statement_or_summary":150},"AESCULAP PNEUMATIC KERRISON","Aesculap, Inc.","Traditional","SESE","Summary",{"k_number":19,"device_name":152,"applicant":153,"decision_date":154,"clearance_type":148,"decision_code":149,"statement_or_summary":150},"ANSPACH POWERED KERRISON SYSTEM (PKS)","The Anspach Effort, Inc.","2002-10-21",{"k_number":20,"device_name":156,"applicant":157,"decision_date":158,"clearance_type":148,"decision_code":149,"statement_or_summary":33},"STAYFREE, UNSCENTED\u002FSCENTED\u002FSCENTED DEODOR MEN PAD","Personal Products Co.","1991-08-02",{"items":160,"total":32},[]]