[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FXW":3},{"classification":4,"mappedDevices":43,"similarCandidates":44,"relatedClassifications":117,"syncDates":205,"translation":212,"marketSummary":218,"recalls":232,"k510s":234,"pmas":242},{"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":38,"updated_at":39,"recall_count":40,"latest_recall_date":41,"k510_count":42,"pma_count":40,"event_count":42},1276,"FXW","Shoes, Operating-Room","1","878.4040","SU","General, Plastic Surgery","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":36,"product_code":6,"review_panel":10,"gmp_exempt_flag":36,"third_party_flag":36,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":36,"medical_specialty_description":11,"summary_malfunction_reporting":37},{"k_number":17,"fei_number":19,"registration_number":34},[18],"K923187",[20,21,22,23,24,25,26,27,28,29,30,31,32,33],"3012251300","3016450032","3008808082","3006113262","3033507138","3004555163","3003965134","3006897996","3011196806","3003653126","3022320321","3017417635","3017212217","3016970619",[20,21,22,23,24,26,27,28,29,30,35,31,32,33],"8030654","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:48.882786+00:00",0,null,1,[],[45,53,60,67,74,81,89,96,103,111],{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":40,"vector_similarity":51,"score":52},4312,"エア式骨手術器械","Ⅰ","70960000",0.217391,0.625062,0.0303309,{"medical_device_id":54,"generic_name":55,"class_classification":48,"jmdn_code":56,"name_similarity":57,"definition_similarity":40,"vector_similarity":58,"score":59},3873,"手術台アクセサリー","70469000",0.195122,0.655238,0.0302135,{"medical_device_id":61,"generic_name":62,"class_classification":48,"jmdn_code":63,"name_similarity":64,"definition_similarity":40,"vector_similarity":65,"score":66},3894,"手術用照明器","12282000",0.37037,0.59494,0.0293805,{"medical_device_id":68,"generic_name":69,"class_classification":48,"jmdn_code":70,"name_similarity":71,"definition_similarity":40,"vector_similarity":72,"score":73},4336,"関節手術用器械","70964001",0.244444,0.591073,0.0280338,{"medical_device_id":75,"generic_name":76,"class_classification":48,"jmdn_code":77,"name_similarity":78,"definition_similarity":40,"vector_similarity":79,"score":80},3878,"手術台システム","37325000",0.222222,0.590539,0.0270125,{"medical_device_id":82,"generic_name":83,"class_classification":84,"jmdn_code":85,"name_similarity":86,"definition_similarity":40,"vector_similarity":87,"score":88},2898,"電池電源式関節手術用器械","Ⅱ","70964022",0.188679,0.58605,0.0249346,{"medical_device_id":90,"generic_name":91,"class_classification":48,"jmdn_code":92,"name_similarity":93,"definition_similarity":40,"vector_similarity":94,"score":95},3871,"婦人科用手術台","36618000",0.155556,0.592332,0.0239598,{"medical_device_id":97,"generic_name":98,"class_classification":48,"jmdn_code":99,"name_similarity":100,"definition_similarity":40,"vector_similarity":101,"score":102},3794,"手術用被覆・保護材","34654000",0.0833333,0.67934,0.0163934,{"medical_device_id":104,"generic_name":105,"class_classification":106,"jmdn_code":107,"name_similarity":108,"definition_similarity":40,"vector_similarity":109,"score":110},958,"再使用可能なフットコントロール式電気手術器用アクティブ電極","Ⅲ","42553000",0.0133333,0.629345,0.015873,{"medical_device_id":112,"generic_name":113,"class_classification":84,"jmdn_code":114,"name_similarity":115,"definition_similarity":40,"vector_similarity":116,"score":110},2894,"単回使用骨手術用器械","70962012",0.23913,0.533952,[118,123,127,131,135,139,143,147,151,155,159,163,167,170,173,177,181,184,187,190,193,196,199,202],{"product_code":119,"device_name":120,"device_class":121,"k510_count":122},"FXX","Mask, Surgical","2",607,{"product_code":124,"device_name":125,"device_class":121,"k510_count":126},"FYA","Gown, Surgical",297,{"product_code":128,"device_name":129,"device_class":121,"k510_count":130},"FYC","Gown, Isolation, Surgical",68,{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"LYU","Accessory, Surgical Apparel",56,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"FXP","Cover, Shoe, Operating-Room",36,{"product_code":140,"device_name":141,"device_class":121,"k510_count":142},"MSH","Respirator, Surgical",35,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"FYF","Cap, Surgical",32,{"product_code":148,"device_name":149,"device_class":121,"k510_count":150},"FXY","Hood, Surgical",13,{"product_code":152,"device_name":153,"device_class":121,"k510_count":154},"QPC","Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection",10,{"product_code":156,"device_name":157,"device_class":121,"k510_count":158},"OXZ","Pediatric\u002FChild Facemask",9,{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"FYE","Dress, Surgical",7,{"product_code":164,"device_name":165,"device_class":8,"k510_count":166},"FXO","Suit, Surgical",6,{"product_code":168,"device_name":169,"device_class":121,"k510_count":166},"FYB","Gown, Patient",{"product_code":171,"device_name":172,"device_class":121,"k510_count":166},"ONT","N95 Respirator With Antimicrobial\u002FAntiviral Agent",{"product_code":174,"device_name":175,"device_class":121,"k510_count":176},"OUK","Surgical Mask With Antimicrobial\u002FAntiviral Agent",4,{"product_code":178,"device_name":179,"device_class":8,"k510_count":180},"BWP","Shoe And Shoe Cover, Conductive",3,{"product_code":182,"device_name":183,"device_class":121,"k510_count":42},"QBW","Surgical Apparel With Material Claims",{"product_code":185,"device_name":186,"device_class":8,"k510_count":40},"FXZ","Helmet, Surgical",{"product_code":188,"device_name":189,"device_class":8,"k510_count":40},"OEA","Non-Surgical Gown",{"product_code":191,"device_name":192,"device_class":121,"k510_count":40},"OKF","Body Fluid Disposal Kit",{"product_code":194,"device_name":195,"device_class":121,"k510_count":40},"OKG","Body Fluid Clean Up Kit",{"product_code":197,"device_name":198,"device_class":121,"k510_count":40},"OKH","Body Fluids Barrier Kit",{"product_code":200,"device_name":201,"device_class":121,"k510_count":40},"OKI","Emergency Response Safety Kit",{"product_code":203,"device_name":204,"device_class":121,"k510_count":40},"QSO","Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs",{"510k":206,"classification":207,"enforcement":208,"event":209,"pma":210,"warning_letter":211},"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":213,"definition_ja":41,"commentary_ja":214,"model_name":215,"source_hash":216,"reviewed_by":41,"reviewed_at":41,"created_at":217,"updated_at":217},"手術室用シューズ","この機器は、手術室内において医療従事者が着用するシューズであり、一般外科・形成外科領域に分類される器具です。米国ではクラスIに区分され、市販前届出（510(k)）が免除されており、リスクが低く一般的な管理のみで安全性・有効性が確保できると判断されている機器であることを意味します。","claude-sonnet-5","1e4ff6244f16b7f9eb0e870daa149b84656adf6dd9930daf3d02864cb4b998a9","2026-08-24T01:52:15.787179+00:00",{"product_code":6,"summary_ja":219,"stats":220,"stats_hash":230,"model_name":215,"created_at":231,"updated_at":231},"本製品はクラス I・届出免除の区分であり、510(k)は累計1件で1993年1月の判定が最新となっています。不具合報告は累計1件で、内容はMalfunction（不具合）によるものであり、直近5年の報告はありません。回収報告は確認されていません。",{"pma":221,"k510":222,"as_of":224,"events":225,"recalls":227,"top_problems":229},{"latest":41,"originals":40,"supplements":40},{"total":42,"last5y":40,"latest":223,"applicants":42},"1993-01-29","2026-08",{"death":40,"other":40,"total":42,"injury":40,"last5y":40,"malfunction":42,"latest_month":226},"1998-05",{"total":40,"last5y":40,"latest":41,"class_i":40,"class_ii":40,"class_iii":40,"top_root_causes":228},[],[],"8ed6c5f44b68a5444694cfb71273749704400bfa6e853a67f97298f566903cf6","2026-08-24T04:25:47.269073+00:00",{"items":233,"total":40},[],{"items":235,"total":42},[236],{"k_number":18,"device_name":237,"applicant":238,"decision_date":223,"clearance_type":239,"decision_code":240,"statement_or_summary":241},"IMPERVIOUS ISOLATION SHOE COVERS","Dynatech Medical Products","Traditional","SESE","Statement",{"items":243,"total":40},[]]