[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-ODR":3},{"classification":4,"mappedDevices":47,"similarCandidates":48,"relatedClassifications":130,"syncDates":214,"translation":221,"marketSummary":228,"recalls":245,"k510s":247,"pmas":264},{"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":41,"updated_at":42,"recall_count":43,"latest_recall_date":44,"k510_count":45,"pma_count":43,"event_count":46},3919,"ODR","Electrosurgical Patient Return Electrode","2","878.4400","SU","General, Plastic Surgery","1","Ground pad used to finish circuit during electrosurgery.  A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":37,"device_class":8,"implant_flag":38,"product_code":6,"review_panel":10,"gmp_exempt_flag":38,"third_party_flag":39,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":37,"life_sustain_support_flag":38,"medical_specialty_description":11,"summary_malfunction_reporting":40},{"k_number":17,"fei_number":21,"registration_number":34},[18,19,20],"K082204","K121268","K160366",[22,23,24,25,26,27,28,29,30,31,32,33],"3006626283","3010230734","3007728276","3039357913","3003749270","3009495876","3001238683","3027267119","1000120578","3029973920","3009513193","3007137643",[22,23,24,25,26,27,35,29,31,32,33,36],"1222993","3032109","","N","Y","Eligible","2026-08-18T05:52:51.341121+00:00","2026-08-24T02:00:47.808424+00:00",0,null,3,256,[],[49,58,66,75,83,91,98,107,115,123],{"medical_device_id":50,"generic_name":51,"class_classification":52,"jmdn_code":53,"name_similarity":54,"definition_similarity":55,"vector_similarity":56,"score":57},932,"治療用対極板","Ⅲ","11500023",0.615385,0.282282,0.764956,0.0317781,{"medical_device_id":59,"generic_name":60,"class_classification":52,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":65},931,"リターンアラーム付対極板","11500013",0.5,0.287582,0.764156,0.0312805,{"medical_device_id":67,"generic_name":68,"class_classification":69,"jmdn_code":70,"name_similarity":71,"definition_similarity":72,"vector_similarity":73,"score":74},2553,"処置用対極板","Ⅱ","11500002",0.404255,0.216828,0.764066,0.0307984,{"medical_device_id":76,"generic_name":77,"class_classification":52,"jmdn_code":78,"name_similarity":79,"definition_similarity":80,"vector_similarity":81,"score":82},957,"再使用可能なハンドコントロール式電気手術器用アクティブ電極","42552000",0.308824,0.272152,0.80029,0.0300179,{"medical_device_id":84,"generic_name":85,"class_classification":52,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},930,"汎用電気手術ユニット","11490000",0.320755,0.273256,0.748048,0.0296313,{"medical_device_id":92,"generic_name":93,"class_classification":52,"jmdn_code":94,"name_similarity":79,"definition_similarity":95,"vector_similarity":96,"score":97},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","42553000",0.238227,0.786764,0.0293865,{"medical_device_id":99,"generic_name":100,"class_classification":101,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":106},3983,"電気手術電極ホルダ","Ⅰ","35043000",0.311111,0.24,0.7442,0.0281914,{"medical_device_id":108,"generic_name":109,"class_classification":52,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},955,"単回使用ハンドコントロール式電気手術器用アクティブ電極","35044000",0.267606,0.288462,0.800719,0.0281581,{"medical_device_id":116,"generic_name":117,"class_classification":69,"jmdn_code":118,"name_similarity":119,"definition_similarity":120,"vector_similarity":121,"score":122},1779,"内視鏡用電気手術器","33602000",0.326531,0.233083,0.716112,0.0273641,{"medical_device_id":124,"generic_name":125,"class_classification":52,"jmdn_code":126,"name_similarity":111,"definition_similarity":127,"vector_similarity":128,"score":129},956,"単回使用フットコントロール式電気手術器用アクティブ電極","70656000",0.259259,0.785556,0.0271193,[131,135,139,143,147,151,155,159,163,167,171,175,179,182,185,188,191,194,198,202,205,208,211],{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"GEI","Electrosurgical, Cutting & Coagulation & Accessories",2312,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"PBX","Massager, Vacuum, Radio Frequency Induced Heat",79,{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"NEY","System, Ablation, Microwave And Accessories",68,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"OCL","Surgical Device, For Cutting, Coagulation, And\u002FOr Ablation Of Tissue, Including Cardiac Tissue",54,{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"NUJ","Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed",37,{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"JOS","Electrode, Electrosurgical",36,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"HAM","Apparatus, Electrosurgical",31,{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"OAB","Low Energy Direct Current Thermal Ablation System",14,{"product_code":164,"device_name":165,"device_class":8,"k510_count":166},"JOT","Electrode, Gel, Electrosurgical",9,{"product_code":168,"device_name":169,"device_class":8,"k510_count":170},"NTB","System, Ablation, Ultrasound And Accessories",6,{"product_code":172,"device_name":173,"device_class":8,"k510_count":174},"OUH","Skin Resurfacing Rf Applicator",5,{"product_code":176,"device_name":177,"device_class":8,"k510_count":178},"DWG","Electrosurgical Device",4,{"product_code":180,"device_name":181,"device_class":8,"k510_count":178},"ONQ","Electrosurgical Coagulation For Aesthetic",{"product_code":183,"device_name":184,"device_class":8,"k510_count":178},"QVJ","Low Power Electrosurgical Devices For Skin Lesion Destruction",{"product_code":186,"device_name":187,"device_class":8,"k510_count":45},"BWA","Unit, Electrosurgical And Coagulation, With Accessories",{"product_code":189,"device_name":190,"device_class":8,"k510_count":45},"MUK","Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue",{"product_code":192,"device_name":193,"device_class":8,"k510_count":45},"OUB","Instrument For Treatment Of Hyperhidrosis",{"product_code":195,"device_name":196,"device_class":8,"k510_count":197},"MWY","System, Microwave, Hair Removal",2,{"product_code":199,"device_name":200,"device_class":8,"k510_count":201},"NVJ","Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women",1,{"product_code":203,"device_name":204,"device_class":8,"k510_count":201},"PDG","Electrosurgical Vessel And\u002FOr Tissue Sealer. With Built-In Generator.",{"product_code":206,"device_name":207,"device_class":8,"k510_count":201},"QUQ","Knife, Intraocular Pressure Lowering",{"product_code":209,"device_name":210,"device_class":8,"k510_count":43},"MUL","Generator, Electrosurgical, Coagulation, Cancer",{"product_code":212,"device_name":213,"device_class":8,"k510_count":43},"SFQ","Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision",{"510k":215,"classification":216,"enforcement":217,"event":218,"pma":219,"warning_letter":220},"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":222,"definition_ja":223,"commentary_ja":224,"model_name":225,"source_hash":226,"reviewed_by":44,"reviewed_at":44,"created_at":227,"updated_at":227},"電気手術用対極板","電気手術中に回路を完成させるために使用されるグランドパッドである。単回使用、非滅菌の分散電極であり、あらかじめコードが取り付けられており、パッド表面全体で患者に密着させることにより、ジェネレータ、能動電極及び患者の間の電気手術回路を完成させるために使用される。","本品は米国においてクラスIIに分類されており、市販前届出（510(k)）による審査を経て市場に流通することになります。この区分は、製品の安全性及び有効性を確保するために、必要に応じて特別管理（性能規格の遵守等）が課される中リスク機器であることを示しています。","claude-sonnet-5","38ef3ea25bae3d1f5f30782d91cf69638b4a74cb57e1ffdda43254e5b4b50906","2026-08-24T02:20:14.132666+00:00",{"product_code":6,"summary_ja":229,"stats":230,"stats_hash":243,"model_name":225,"created_at":244,"updated_at":244},"米国FDAの510(k)は累計3件で、参入企業数は3社です。直近5年間の新規届出は確認されていません。不具合報告は累計約260件で、内訳は死亡1件、傷害約100件、不具合（Malfunction）約130件、その他約20件となっており、死亡・傷害を合わせた件数が不具合報告全体の半数近くを占めています。回収（リコール）の報告は確認されていません。",{"pma":231,"k510":232,"as_of":234,"events":235,"recalls":240,"top_problems":242},{"latest":44,"originals":43,"supplements":43},{"total":45,"last5y":43,"latest":233,"applicants":45},"2016-08-19","2026-08",{"death":201,"other":236,"total":46,"injury":237,"last5y":197,"malfunction":238,"latest_month":239},22,103,130,"2026-06",{"total":43,"last5y":43,"latest":44,"class_i":43,"class_ii":43,"class_iii":43,"top_root_causes":241},[],[],"e3c6a9de66f7008b09d6afe7509bf2511d97abe828b295997160804406ceef99","2026-08-24T05:03:24.690751+00:00",{"items":246,"total":43},[],{"items":248,"total":45},[249,255,259],{"k_number":20,"device_name":250,"applicant":251,"decision_date":233,"clearance_type":252,"decision_code":253,"statement_or_summary":254},"Electrosurgical disposable grounding pads","Top-Rank Health Care Co., Ltd.","Traditional","SESE","Summary",{"k_number":19,"device_name":256,"applicant":257,"decision_date":258,"clearance_type":252,"decision_code":253,"statement_or_summary":254},"WANDY DISPERSVIE ELECTRODE","Bio-Med USA, Inc.","2012-12-20",{"k_number":18,"device_name":260,"applicant":261,"decision_date":262,"clearance_type":252,"decision_code":253,"statement_or_summary":263},"SERIES SY DISPOSABLE ELECTROSURGICAL PAD","Ventlab Corp.","2008-08-13","Statement",{"items":265,"total":43},[]]