[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PJH":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":115,"syncDates":116,"translation":123,"marketSummary":130,"recalls":143,"k510s":145,"pmas":159},{"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":27,"updated_at":28,"recall_count":29,"latest_recall_date":30,"k510_count":31,"pma_count":29,"event_count":29},49,"PJH","Dynamic Rectal Control System","2","876.5930","GU","Gastroenterology, Urology","1","Intended to treat fecal incontinence by controlling the size of the rectal lumen.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":24,"device_class":8,"implant_flag":25,"product_code":6,"review_panel":10,"gmp_exempt_flag":25,"third_party_flag":25,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":24,"life_sustain_support_flag":25,"medical_specialty_description":11,"summary_malfunction_reporting":26},{"k_number":17,"fei_number":20,"registration_number":22},[18,19],"K150558","DEN140020",[21],"1000220650",[23],"1722684","","N","Eligible","2026-08-18T05:52:47.660896+00:00","2026-08-24T02:00:49.285889+00:00",0,null,2,[],[34,43,52,60,68,76,83,92,99,107],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":40,"vector_similarity":41,"score":42},3848,"大腸灌流装置","Ⅰ","43827000",0.217391,0.137795,0.723966,0.029116,{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},2232,"外科手術用直腸クランプ","Ⅱ","35542002",0.214286,0.204969,0.710991,0.0290404,{"medical_device_id":53,"generic_name":54,"class_classification":37,"jmdn_code":55,"name_similarity":56,"definition_similarity":57,"vector_similarity":58,"score":59},4357,"直腸拡張器具","11262000",0.216216,0.122302,0.721004,0.028373,{"medical_device_id":61,"generic_name":62,"class_classification":46,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},3182,"直腸用プラグ","46193002",0.2,0.258065,0.688105,0.027032,{"medical_device_id":69,"generic_name":70,"class_classification":46,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},2053,"直腸用カテーテル","10746000",0.210526,0.107438,0.706198,0.0265533,{"medical_device_id":77,"generic_name":78,"class_classification":46,"jmdn_code":79,"name_similarity":64,"definition_similarity":80,"vector_similarity":81,"score":82},1914,"直腸用チューブ","14227000",0.142857,0.669488,0.0234311,{"medical_device_id":84,"generic_name":85,"class_classification":86,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},664,"人工肛門括約筋補綴材","Ⅲ","34092000",0.037037,0.44,0.757327,0.0163934,{"medical_device_id":93,"generic_name":94,"class_classification":46,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":91},2556,"トレパンシステムコントロールユニット","43928000",0.340909,0.187817,0.616064,{"medical_device_id":100,"generic_name":101,"class_classification":86,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":106},692,"透析用監視装置","36424000",0.326531,0.0738636,0.625998,0.016129,{"medical_device_id":108,"generic_name":109,"class_classification":46,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},1429,"尿動態測定システム","14307000",0.276596,0.13913,0.650936,0.015873,[],{"510k":117,"classification":118,"enforcement":119,"event":120,"pma":121,"warning_letter":122},"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":124,"definition_ja":125,"commentary_ja":126,"model_name":127,"source_hash":128,"reviewed_by":30,"reviewed_at":30,"created_at":129,"updated_at":129},"動的直腸内腔調整システム","直腸内腔の大きさを制御することにより便失禁を治療することを意図する。","本品は米国では消化器・泌尿器領域の医療機器としてクラスIIに分類されており、市販前届出（510(k)）の対象となっています。クラスIIは、性能規格や特別なコントロールを課すことで安全性と有効性を確保できると判断される中程度のリスクを有する機器区分であり、クラスIIIの機器に求められる市販前承認（PMA）のような厳格な審査は不要とされています。","claude-sonnet-5","a2bdb5b9ea247f76d523c5a9493362675fd59f228bd734e9cb5fb42979b3d04c","2026-08-24T02:30:13.381035+00:00",{"product_code":6,"summary_ja":131,"stats":132,"stats_hash":141,"model_name":127,"created_at":142,"updated_at":142},"510(k)の累計届出は2件で、参入企業数は2社となっていますが、直近5年間の届出実績は確認されていません。不具合報告および回収については、いずれも累計件数0件であり、報告は確認されていません。",{"pma":133,"k510":134,"as_of":136,"events":137,"recalls":138,"top_problems":140},{"latest":30,"originals":29,"supplements":29},{"total":31,"last5y":29,"latest":135,"applicants":31},"2015-11-12","2026-08",{"death":29,"other":29,"total":29,"injury":29,"last5y":29,"malfunction":29,"latest_month":30},{"total":29,"last5y":29,"latest":30,"class_i":29,"class_ii":29,"class_iii":29,"top_root_causes":139},[],[],"77d165323a25837169aff90226b17cec83d7b68fd36be46deea8609a377c3f06","2026-08-24T05:09:58.149854+00:00",{"items":144,"total":29},[],{"items":146,"total":31},[147,153],{"k_number":18,"device_name":148,"applicant":149,"decision_date":135,"clearance_type":150,"decision_code":151,"statement_or_summary":152},"Eclipse System","Pelvalon, Inc.","Traditional","SESE","Summary",{"k_number":19,"device_name":154,"applicant":155,"decision_date":156,"clearance_type":157,"decision_code":158,"statement_or_summary":30},"ECLIPSE SYSTEM","Pelvalon","2015-02-12","Direct","DENG",{"items":160,"total":29},[]]