[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HDN":3},{"classification":4,"mappedDevices":25,"similarCandidates":26,"relatedClassifications":109,"syncDates":110,"translation":117,"marketSummary":124,"recalls":139,"k510s":141,"pmas":143},{"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":20,"updated_at":21,"recall_count":22,"latest_recall_date":23,"k510_count":22,"pma_count":22,"event_count":24},2737,"HDN","Dilator, Cervical, Expandable","3","884.4250","OB","Obstetrics\u002FGynecology","2","Call for PMAs to be filed by 12\u002F26\u002F96 per 61 FR 50708 on 9\u002F27\u002F96",false,{"openfda":16,"definition":13,"device_name":7,"review_code":17,"device_class":8,"implant_flag":18,"product_code":6,"review_panel":10,"gmp_exempt_flag":18,"third_party_flag":18,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":17,"life_sustain_support_flag":18,"medical_specialty_description":11,"summary_malfunction_reporting":19},{},"","N","Ineligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:48.882786+00:00",0,null,3,[],[27,36,44,52,61,69,78,86,93,101],{"medical_device_id":28,"generic_name":29,"class_classification":30,"jmdn_code":31,"name_similarity":32,"definition_similarity":33,"vector_similarity":34,"score":35},3710,"子宮頚管拡張器","Ⅰ","70344000",0.607143,0.0797101,0.700355,0.0327869,{"medical_device_id":37,"generic_name":38,"class_classification":30,"jmdn_code":39,"name_similarity":40,"definition_similarity":41,"vector_similarity":42,"score":43},4355,"拡張器","11254000",0.285714,0.0814815,0.634773,0.031746,{"medical_device_id":45,"generic_name":46,"class_classification":30,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},4366,"医療用拡張器","70969001",0.358974,0.0707965,0.62132,0.0300179,{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},532,"皮膚拡張器","Ⅲ","70443003",0.272727,0.0532544,0.624043,0.0296313,{"medical_device_id":62,"generic_name":63,"class_classification":30,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":68},4360,"膣拡張器具","11267000",0.257143,0.0742574,0.61907,0.0279843,{"medical_device_id":70,"generic_name":71,"class_classification":72,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},2905,"単回使用医療用拡張器","Ⅱ","70969002",0.27907,0.0620155,0.586417,0.0272529,{"medical_device_id":79,"generic_name":80,"class_classification":30,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":85},4357,"直腸拡張器具","11262000",0.264706,0.0923077,0.602517,0.027151,{"medical_device_id":87,"generic_name":88,"class_classification":30,"jmdn_code":89,"name_similarity":57,"definition_similarity":90,"vector_similarity":91,"score":92},3467,"再使用可能な内視鏡用拡張器","37142000",0.0675676,0.587061,0.0271493,{"medical_device_id":94,"generic_name":95,"class_classification":72,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":100},2904,"カテーテル拡張器","32338000",0.230769,0.112,0.617381,0.0268468,{"medical_device_id":102,"generic_name":103,"class_classification":30,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":108},4362,"食道拡張器","35009000",0.27027,0.0607477,0.592245,0.0267541,[],{"510k":111,"classification":112,"enforcement":113,"event":114,"pma":115,"warning_letter":116},"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":118,"definition_ja":119,"commentary_ja":120,"model_name":121,"source_hash":122,"reviewed_by":23,"reviewed_at":23,"created_at":123,"updated_at":123},"拡張式頸管拡張器","1996年9月27日付連邦官報61 FR 50708に基づき、1996年12月26日までに市販前承認（PMA）を提出することを求める。","本品は米国FDAの規制上クラスIIIに分類されており、市販に先立って市販前承認（PMA）による審査を受ける必要があります。クラスIIIはFDAの分類の中で最も規制が厳しい区分であり、人体への高いリスクが想定される医療機器や、有効性・安全性を裏付ける十分な科学的データが確立されていない機器が対象となります。510(k)（市販前届出）による既存品との実質的同等性の証明では市販が認められず、臨床データ等を含む包括的な資料に基づく個別審査が求められます。","claude-sonnet-5","77faedf13801d18f9dc432f0055a4aeebaa780dec858c03cc9b50420bed521f9","2026-08-24T01:55:21.85667+00:00",{"product_code":6,"summary_ja":125,"stats":126,"stats_hash":137,"model_name":121,"created_at":138,"updated_at":138},"本製品コードにおいては、510(k)・PMAともに累計件数は0件であり、市場での届出・承認実績は確認されていません。不具合報告（MDR）は累計約3件で、内訳は傷害が2件、不具合（Malfunction）が1件となっており、最新の報告は2006年9月です。直近5年間の報告件数は0件です。回収（リコール）についても累計0件で、クラスI・II・IIIいずれも確認されていません。",{"pma":127,"k510":128,"as_of":129,"events":130,"recalls":134,"top_problems":136},{"latest":23,"originals":22,"supplements":22},{"total":22,"last5y":22,"latest":23,"applicants":22},"2026-08",{"death":22,"other":22,"total":24,"injury":131,"last5y":22,"malfunction":132,"latest_month":133},2,1,"2006-09",{"total":22,"last5y":22,"latest":23,"class_i":22,"class_ii":22,"class_iii":22,"top_root_causes":135},[],[],"3c4ada0cc912bc7eb5b76c99b81f8bafd7501a448eccb3ae0056ed0ef8f13e1e","2026-08-24T04:30:57.116764+00:00",{"items":140,"total":22},[],{"items":142,"total":22},[],{"items":144,"total":22},[]]