[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LHY":3},{"classification":4,"mappedDevices":28,"similarCandidates":29,"relatedClassifications":103,"syncDates":104,"translation":111,"marketSummary":117,"recalls":131,"k510s":133,"pmas":135},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":9,"implant_flag":13,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":24,"pma_count":26,"event_count":27},4582,"LHY","Electrode, Stabilized Epidural Spinal","3","","Unknown","NE","2",true,false,{"openfda":16,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":11,"gmp_exempt_flag":20,"third_party_flag":20,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":20,"medical_specialty_description":10,"summary_malfunction_reporting":21},{"pma_number":17},[18],"P810033","Y","N","Ineligible","2026-08-18T05:52:52.082407+00:00","2026-08-24T02:00:48.095002+00:00",0,null,1,3,[],[30,38,46,53,61,68,75,82,89,96],{"medical_device_id":31,"generic_name":32,"class_classification":33,"jmdn_code":34,"name_similarity":35,"definition_similarity":24,"vector_similarity":36,"score":37},358,"脊髄くも膜下・硬膜外針","Ⅲ","36191020",0.283019,0.722345,0.0327869,{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":24,"vector_similarity":44,"score":45},3364,"胎児頭皮用クリップ電極","Ⅰ","42560000",0.244898,0.680236,0.0277459,{"medical_device_id":47,"generic_name":48,"class_classification":41,"jmdn_code":49,"name_similarity":50,"definition_similarity":24,"vector_similarity":51,"score":52},3363,"表面用胎児頭皮向け電極","35038001",0.235294,0.68035,0.0274798,{"medical_device_id":54,"generic_name":55,"class_classification":56,"jmdn_code":57,"name_similarity":58,"definition_similarity":24,"vector_similarity":59,"score":60},2531,"電気ショック用電極","Ⅱ","11444000",0.25,0.672591,0.0274328,{"medical_device_id":62,"generic_name":63,"class_classification":56,"jmdn_code":64,"name_similarity":65,"definition_similarity":24,"vector_similarity":66,"score":67},2567,"再使用可能な脱毛器用針電極","38798000",0.218182,0.680686,0.0261449,{"medical_device_id":69,"generic_name":70,"class_classification":41,"jmdn_code":71,"name_similarity":72,"definition_similarity":24,"vector_similarity":73,"score":74},3362,"眼球電位用電極","35036000",0.222222,0.678026,0.0259916,{"medical_device_id":76,"generic_name":77,"class_classification":41,"jmdn_code":78,"name_similarity":79,"definition_similarity":24,"vector_similarity":80,"score":81},3356,"体表面電気刺激装置用電極","34374001",0.206897,0.689966,0.0257124,{"medical_device_id":83,"generic_name":84,"class_classification":33,"jmdn_code":85,"name_similarity":86,"definition_similarity":24,"vector_similarity":87,"score":88},437,"硬膜外カテーテル","34898000",0.209302,0.683187,0.0255617,{"medical_device_id":90,"generic_name":91,"class_classification":56,"jmdn_code":92,"name_similarity":93,"definition_similarity":24,"vector_similarity":94,"score":95},1473,"電気刺激装置用針電極","34374102",0.226415,0.670973,0.0254183,{"medical_device_id":97,"generic_name":98,"class_classification":41,"jmdn_code":99,"name_similarity":100,"definition_similarity":24,"vector_similarity":101,"score":102},3983,"電気手術電極ホルダ","35043000",0.204082,0.6856,0.0251248,[],{"510k":105,"classification":106,"enforcement":107,"event":108,"pma":109,"warning_letter":110},"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":112,"definition_ja":25,"commentary_ja":113,"model_name":114,"source_hash":115,"reviewed_by":25,"reviewed_at":25,"created_at":116,"updated_at":116},"固定式硬膜外脊髄電極","この製品は米国FDAの規制上クラスIIIに分類される医療機器です。クラスIIIは人体へのリスクが最も高いとされる区分であり、市販前承認（PMA）による厳格な審査を経て、有効性および安全性に関する科学的な証拠の提出が求められます。","claude-sonnet-5","99cc1e8cfa50d7e6f051f74a79f06d54a9414fe110c0b03bd5ccadf54ca8326a","2026-08-24T02:11:36.699753+00:00",{"product_code":6,"summary_ja":118,"stats":119,"stats_hash":129,"model_name":114,"created_at":130,"updated_at":130},"本製品はPMA（市販前承認）区分の機器で、本承認が1件（1982年2月）確認されていますが、一部変更承認や510(k)の届出実績は確認されていません。不具合報告は累計約3件で、その全てが傷害（Injury）として報告されており、死亡や不具合（Malfunction）の報告は確認されていません。回収については、クラスI・II・IIIのいずれも報告例は確認されていません。",{"pma":120,"k510":122,"as_of":123,"events":124,"recalls":126,"top_problems":128},{"latest":121,"originals":26,"supplements":24},"1982-02-02",{"total":24,"last5y":24,"latest":25,"applicants":24},"2026-08",{"death":24,"other":24,"total":27,"injury":27,"last5y":24,"malfunction":24,"latest_month":125},"2007-03",{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":127},[],[],"3eb98697bf183d478dc5d88496d688ab25ecf081002727307e7e8022a3dbfbd1","2026-08-24T04:50:56.354429+00:00",{"items":132,"total":24},[],{"items":134,"total":24},[],{"items":136,"total":26},[137],{"pma_number":18,"supplement_number":9,"trade_name":138,"applicant":139,"decision_date":121},"SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355","Avery Biomedical Devices, Inc."]