[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-EZB":3},{"classification":4,"mappedDevices":93,"similarCandidates":94,"relatedClassifications":168,"syncDates":265},{"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":86,"updated_at":87,"recall_count":88,"latest_recall_date":89,"k510_count":90,"pma_count":91,"event_count":92},5121,"EZB","Stylet For Catheter, Gastro-Urology","1","876.5130","GU","Gastroenterology, Urology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":84,"product_code":6,"review_panel":10,"gmp_exempt_flag":84,"third_party_flag":84,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":84,"medical_specialty_description":11,"summary_malfunction_reporting":85},{"k_number":17,"fei_number":21,"registration_number":70},[18,19,20],"K970994","K874164","K971498",[22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69],"3014334038","3002750084","1820334","1000121056","3002770040","3006509795","3003418325","3004215117","3002807214","3009763019","3004365956","2521453","3002807314","3004579081","2183744","3005987240","3004134316","2027111","3005099803","3005809810","3004859241","3008988055","3009051888","3010273872","3003052153","3002807264","3012267976","3004216008","3007695959","3001436772","2126666","1018233","1825146","3001644167","3004608878","3017210488","3002807439","1000237915","2124215","3006082230","3010155661","3010041511","1313046","3013666336","3002806565","1923569","3005747797","3006279007",[22,24,71,25,72,28,29,73,31,32,74,34,33,35,36,75,37,38,39,76,77,78,40,41,42,43,79,44,45,80,48,81,50,52,82,53,54,55,56,57,83,60,61,62,63,64,65,67],"9681477","9613079","9616067","1836161","9617744","1651252","9681260","9611610","3011137372","9611590","8040278","8030607","9616246","N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-19T02:30:42.714273+00:00",13,"2020-04-29",3,0,2442,[],[95,103,111,118,126,133,140,147,154,161],{"medical_device_id":96,"generic_name":97,"class_classification":98,"jmdn_code":99,"name_similarity":100,"definition_similarity":91,"vector_similarity":101,"score":102},1987,"クデー泌尿器用カテーテル","Ⅱ","31981000",0.333333,0.725387,0.031746,{"medical_device_id":104,"generic_name":105,"class_classification":106,"jmdn_code":107,"name_similarity":108,"definition_similarity":91,"vector_similarity":109,"score":110},73,"弁拡張向けカテーテル用ガイドワイヤ及びスタイレット","Ⅳ","70276000",0.269841,0.752102,0.0295513,{"medical_device_id":112,"generic_name":113,"class_classification":98,"jmdn_code":114,"name_similarity":115,"definition_similarity":91,"vector_similarity":116,"score":117},1995,"洗浄向け泌尿器用カテーテル","34930010",0.294118,0.696688,0.0288143,{"medical_device_id":119,"generic_name":120,"class_classification":121,"jmdn_code":122,"name_similarity":123,"definition_similarity":91,"vector_similarity":124,"score":125},383,"瘻排液向け泌尿器用カテーテル","Ⅲ","31074009",0.320755,0.683604,0.028612,{"medical_device_id":127,"generic_name":128,"class_classification":98,"jmdn_code":129,"name_similarity":130,"definition_similarity":91,"vector_similarity":131,"score":132},1989,"尿管向け泌尿器用カテーテル","34926012",0.275,0.708723,0.0284389,{"medical_device_id":134,"generic_name":135,"class_classification":98,"jmdn_code":136,"name_similarity":137,"definition_similarity":91,"vector_similarity":138,"score":139},2006,"経皮泌尿器用カテーテル","70264000",0.283019,0.699005,0.028169,{"medical_device_id":141,"generic_name":142,"class_classification":98,"jmdn_code":143,"name_similarity":144,"definition_similarity":91,"vector_similarity":145,"score":146},2367,"泌尿器用ステント位置補正カテーテル","70492000",0.293103,0.684687,0.0278638,{"medical_device_id":148,"generic_name":149,"class_classification":98,"jmdn_code":150,"name_similarity":151,"definition_similarity":91,"vector_similarity":152,"score":153},2004,"追跡型泌尿器用糸状カテーテル","32022000",0.339623,0.673627,0.0276233,{"medical_device_id":155,"generic_name":156,"class_classification":98,"jmdn_code":157,"name_similarity":158,"definition_similarity":91,"vector_similarity":159,"score":160},2097,"消化器用カテーテルイントロデューサ","70329000",0.277778,0.678392,0.0263569,{"medical_device_id":162,"generic_name":163,"class_classification":98,"jmdn_code":164,"name_similarity":165,"definition_similarity":91,"vector_similarity":166,"score":167},1991,"間欠泌尿器用カテーテル","36125000",0.288462,0.669241,0.0256039,[169,174,178,182,186,190,194,198,201,205,209,213,216,220,223,226,229,232,235,238,241,244,247,250,253,256,259,262],{"product_code":170,"device_name":171,"device_class":172,"k510_count":173},"KOD","Catheter, Urological","2",238,{"product_code":175,"device_name":176,"device_class":172,"k510_count":177},"EZL","Catheter, Retention Type, Balloon",129,{"product_code":179,"device_name":180,"device_class":172,"k510_count":181},"EZD","Catheter, Straight",86,{"product_code":183,"device_name":184,"device_class":172,"k510_count":185},"GBM","Catheter, Urethral",71,{"product_code":187,"device_name":188,"device_class":172,"k510_count":189},"KNY","Accessories, Catheter, G-U",65,{"product_code":191,"device_name":192,"device_class":172,"k510_count":193},"FCM","Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)",60,{"product_code":195,"device_name":196,"device_class":172,"k510_count":197},"EYB","Catheter, Ureteral, Gastro-Urology",28,{"product_code":199,"device_name":200,"device_class":172,"k510_count":197},"LJH","System, Irrigation, Urological",{"product_code":202,"device_name":203,"device_class":172,"k510_count":204},"MJC","Catheter, Urological (Antimicrobial) And Accessories",10,{"product_code":206,"device_name":207,"device_class":172,"k510_count":208},"EZC","Catheter, Coude",7,{"product_code":210,"device_name":211,"device_class":172,"k510_count":212},"EYC","Catheter, Upper Urinary Tract",5,{"product_code":214,"device_name":215,"device_class":172,"k510_count":90},"FGI","Catheter, Urethrographic, Male",{"product_code":217,"device_name":218,"device_class":8,"k510_count":219},"EYK","Connector, Ureteral Catheter",1,{"product_code":221,"device_name":222,"device_class":172,"k510_count":219},"FGF","Catheter, Ureteral Disposable (X-Ray)",{"product_code":224,"device_name":225,"device_class":172,"k510_count":219},"FGH","Catheter, Double Lumen Female Urethrographic",{"product_code":227,"device_name":228,"device_class":172,"k510_count":219},"NWO","Kit, Catheter, Urinary (Exludes Hiv Testing)",{"product_code":230,"device_name":231,"device_class":8,"k510_count":91},"EYA","Stylet, Ureteral",{"product_code":233,"device_name":234,"device_class":8,"k510_count":91},"EYI","Adaptor, Ureteral Catheter",{"product_code":236,"device_name":237,"device_class":8,"k510_count":91},"EYJ","Holder, Ureteral Catheter",{"product_code":239,"device_name":240,"device_class":84,"k510_count":91},"GBL","Catheter, Ureteral, General & Plastic Surgery",{"product_code":242,"device_name":243,"device_class":172,"k510_count":91},"OHR","Catheter Care Tray",{"product_code":245,"device_name":246,"device_class":172,"k510_count":91},"PPA","Bladder Irrigation Kit",{"product_code":248,"device_name":249,"device_class":172,"k510_count":91},"PPB","Foley Catheter Kit (Excludes Hiv Testing)",{"product_code":251,"device_name":252,"device_class":172,"k510_count":91},"PPC","Male External Catheterization Kit (Excludes Hiv Testing)",{"product_code":254,"device_name":255,"device_class":172,"k510_count":91},"PPD","Universal Drainage Tray",{"product_code":257,"device_name":258,"device_class":172,"k510_count":91},"PPF","Urinary Irrigation Kit",{"product_code":260,"device_name":261,"device_class":172,"k510_count":91},"PPG","Urinary Drainage Collection Kit",{"product_code":263,"device_name":264,"device_class":172,"k510_count":91},"SCT","Foley Catheters And Accessories With Additional Safety Features",{"510k":266,"classification":267,"enforcement":268,"event":269,"pma":270,"warning_letter":271},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-19T04:07:02.603+00:00"]