[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PEW":3},{"classification":4,"mappedDevices":56,"similarCandidates":57,"relatedClassifications":140,"syncDates":141},{"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":15,"gmp_exempt_flag":15,"raw":16,"created_at":49,"updated_at":50,"recall_count":51,"latest_recall_date":52,"k510_count":53,"pma_count":54,"event_count":55},1045,"PEW","Implantable Transprostatic Tissue Retractor System","2","876.5530","GU","Gastroenterology, Urology","1","The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":45,"device_class":8,"implant_flag":46,"product_code":6,"review_panel":10,"gmp_exempt_flag":47,"third_party_flag":47,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":45,"life_sustain_support_flag":47,"medical_specialty_description":11,"summary_malfunction_reporting":48},{"k_number":18,"fei_number":30,"registration_number":40},[19,20,21,22,23,24,25,26,27,28,29],"K173087","K200441","K193269","K153584","K162345","K201837","K172359","DEN130023","K133281","K190377","K232558",[31,32,33,34,35,36,37,38,39],"3010220595","3000215205","3005747797","1000306431","3010041511","3005791775","3009307931","3003898360","3002907620",[41,42,31,43,35,37,38,39,44],"2953359","3015181082","2029275","3011137372","","Y","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-19T02:30:42.714273+00:00",2,"2022-08-10",11,0,466,[],[58,67,75,84,92,101,109,116,124,132],{"medical_device_id":59,"generic_name":60,"class_classification":61,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},1148,"植込み型前立腺組織牽引システム","Ⅲ","58882003",0.862745,0.168889,0.87084,0.0327869,{"medical_device_id":68,"generic_name":69,"class_classification":61,"jmdn_code":70,"name_similarity":71,"definition_similarity":72,"vector_similarity":73,"score":74},1185,"前立腺組織用水蒸気デリバリーシステム","71095003",0.302632,0.15625,0.722217,0.0312576,{"medical_device_id":76,"generic_name":77,"class_classification":78,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},4273,"開創器","Ⅰ","13373001",0.245283,0.151376,0.711869,0.0291385,{"medical_device_id":85,"generic_name":86,"class_classification":61,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},665,"体内用失禁補綴材","34214100",0.217391,0.177665,0.690523,0.0269928,{"medical_device_id":93,"generic_name":94,"class_classification":95,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":100},260,"体内用吸収性合成・炭素繊維補綴材","Ⅳ","33473204",0.291667,0.120438,0.663943,0.0267794,{"medical_device_id":102,"generic_name":103,"class_classification":61,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":108},595,"体内固定システム","35642003",0.350877,0.16609,0.637806,0.016129,{"medical_device_id":110,"generic_name":111,"class_classification":78,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":108},4275,"泌尿器科用開創器","35311000",0.166667,0.139194,0.72255,{"medical_device_id":117,"generic_name":118,"class_classification":95,"jmdn_code":119,"name_similarity":120,"definition_similarity":121,"vector_similarity":122,"score":123},168,"吸収性体内固定用組織ステープル","35615004",0.318841,0.11336,0.62849,0.015873,{"medical_device_id":125,"generic_name":126,"class_classification":95,"jmdn_code":127,"name_similarity":128,"definition_similarity":129,"vector_similarity":130,"score":131},238,"吸収性体内固定システム","35642004",0.307692,0.149826,0.644014,0.015625,{"medical_device_id":133,"generic_name":134,"class_classification":61,"jmdn_code":135,"name_similarity":136,"definition_similarity":137,"vector_similarity":138,"score":139},666,"コラーゲン使用体内用失禁補綴材","34214200",0.178571,0.19917,0.705165,0.0153846,[],{"510k":142,"classification":143,"enforcement":144,"event":145,"pma":146,"warning_letter":147},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:29:12.941+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]