[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QTN":3},{"classification":4,"mappedDevices":35,"similarCandidates":36,"relatedClassifications":116,"syncDates":117,"translation":124,"marketSummary":131,"recalls":151,"k510s":153,"pmas":167},{"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":29,"updated_at":30,"recall_count":31,"latest_recall_date":32,"k510_count":33,"pma_count":31,"event_count":34},3145,"QTN","Orally Ingested Transient Device For Constipation","2","876.5940","GU","Gastroenterology, Urology","1","An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":26,"device_class":8,"implant_flag":27,"product_code":6,"review_panel":10,"gmp_exempt_flag":27,"third_party_flag":27,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":26,"life_sustain_support_flag":27,"medical_specialty_description":11,"summary_malfunction_reporting":28},{"k_number":17,"fei_number":21,"registration_number":24},[18,19,20],"K232830","K223031","DEN210052",[22,23],"3025305436","3010666513",[22,25],"3011782009","","N","Ineligible","2026-08-18T05:52:50.955415+00:00","2026-08-24T02:00:48.758894+00:00",0,null,3,24,[],[37,46,55,64,71,80,86,94,101,109],{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":43,"vector_similarity":44,"score":45},2987,"カプセル型撮像及び追跡装置","Ⅱ","71027000",0.183099,0.266667,0.732708,0.0278877,{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":52,"vector_similarity":53,"score":54},3986,"アブレーション装置接続用ケーブル及びスイッチ","Ⅰ","70658000",0.28169,0.206294,0.538663,0.0163934,{"medical_device_id":56,"generic_name":57,"class_classification":58,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},302,"植込み型失禁用神経筋電気刺激装置","Ⅳ","36175000",0.0582524,0.214286,0.693697,0.016129,{"medical_device_id":65,"generic_name":66,"class_classification":40,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":63},3179,"中耳加圧装置","47542002",0.272727,0.181818,0.634838,{"medical_device_id":72,"generic_name":73,"class_classification":74,"jmdn_code":75,"name_similarity":76,"definition_similarity":77,"vector_similarity":78,"score":79},657,"機械式・水圧式植込み失禁器具","Ⅲ","31994000",0.10989,0.166189,0.693533,0.015873,{"medical_device_id":81,"generic_name":82,"class_classification":49,"jmdn_code":83,"name_similarity":61,"definition_similarity":84,"vector_similarity":85,"score":79},3281,"骨盤画像診断・放射線治療用患者体位固定具","40901000",0.228571,0.578479,{"medical_device_id":87,"generic_name":88,"class_classification":74,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":93},838,"失禁用神経筋電気刺激装置","36784000",0.0652174,0.188406,0.693182,0.015625,{"medical_device_id":95,"generic_name":96,"class_classification":74,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":93},1125,"植込み能動型機器管理用プログラム","71052003",0.217949,0.190217,0.571357,{"medical_device_id":102,"generic_name":103,"class_classification":58,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":108},304,"植込み型排尿・排便機能制御用スティミュレータ","70599000",0.105263,0.197368,0.692968,0.0153846,{"medical_device_id":110,"generic_name":111,"class_classification":40,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":108},1891,"侵襲式単回使用トロカールスリーブ固定具","70222000",0.209877,0.234973,0.558489,[],{"510k":118,"classification":119,"enforcement":120,"event":121,"pma":122,"warning_letter":123},"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":125,"definition_ja":126,"commentary_ja":127,"model_name":128,"source_hash":129,"reviewed_by":32,"reviewed_at":32,"created_at":130,"updated_at":130},"便秘治療用経口摂取型一過性デバイス","便秘のための経口摂取型一過性デバイスとは、便秘の治療のために消化管を自然に通過する、電気式の飲み込み可能なカプセルである。","米国ではクラスIIに分類されており、市販前届出（510(k)）の手続きにより安全性と有効性が確認される区分に位置付けられています。この審査区分は、既存の同等な機器との実質的同等性を示すことで市販が認められる仕組みであり、クラスIIIの機器に求められる市販前承認（PMA）よりも簡便な手続きとなっています。","claude-sonnet-5","a633d5801ae698880fccf8a061f22fe603ab596d16563d58d834fbfb3f05ab29","2026-08-24T03:33:38.802601+00:00",{"product_code":6,"summary_ja":132,"stats":133,"stats_hash":149,"model_name":128,"created_at":150,"updated_at":150},"510(k)としての届出は累計3件で、直近5年間も3件、申請企業数は1社となっています。不具合報告（MDR）は累計約20件で、内訳は死亡0件、傷害15件、不具合9件と傷害に関する報告が中心を占めています。主な問題としては、Patient Device Interaction Problem（患者と機器の相互作用に関する問題）、Positioning Problem（位置に関する問題）、Prophylactic removal due to corrective action（是正措置に伴う予防的除去）が挙げられています。なお、回収（リコール）については確認されていません。",{"pma":134,"k510":135,"as_of":138,"events":139,"recalls":143,"top_problems":145},{"latest":32,"originals":31,"supplements":31},{"total":33,"last5y":33,"latest":136,"applicants":137},"2023-12-08",1,"2026-08",{"death":31,"other":31,"total":34,"injury":140,"last5y":34,"malfunction":141,"latest_month":142},15,9,"2026-05",{"total":31,"last5y":31,"latest":32,"class_i":31,"class_ii":31,"class_iii":31,"top_root_causes":144},[],[146,147,148],"Patient Device Interaction Problem","Positioning Problem","Prophylactic removal due to corrective action","02b4fd1cdd4f977de3d0c2fbf3e951eec61558454e26a4d0e84088c1bb85096f","2026-08-24T05:21:03.140427+00:00",{"items":152,"total":31},[],{"items":154,"total":33},[155,161,163],{"k_number":18,"device_name":156,"applicant":157,"decision_date":136,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"Vibrant System","Vibrant, Ltd.","Traditional","SESE","Summary",{"k_number":19,"device_name":156,"applicant":157,"decision_date":162,"clearance_type":158,"decision_code":159,"statement_or_summary":160},"2023-01-13",{"k_number":20,"device_name":156,"applicant":157,"decision_date":164,"clearance_type":165,"decision_code":166,"statement_or_summary":32},"2022-08-26","Direct","DENG",{"items":168,"total":31},[]]