[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FGF":3},{"classification":4,"mappedDevices":28,"similarCandidates":29,"relatedClassifications":103,"syncDates":198,"translation":205,"marketSummary":211,"recalls":227,"k510s":229,"pmas":236},{"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":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":26,"pma_count":24,"event_count":27},115,"FGF","Catheter, Ureteral Disposable (X-Ray)","2","876.5130","GU","Gastroenterology, Urology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":10,"gmp_exempt_flag":19,"third_party_flag":20,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":19,"medical_specialty_description":11,"summary_malfunction_reporting":21},{"k_number":17},[18],"K903994","N","Y","Eligible","2026-08-18T05:52:47.660896+00:00","2026-08-24T02:00:48.882786+00:00",0,null,1,28,[],[30,38,45,52,59,66,74,81,88,95],{"medical_device_id":31,"generic_name":32,"class_classification":33,"jmdn_code":34,"name_similarity":35,"definition_similarity":24,"vector_similarity":36,"score":37},1989,"尿管向け泌尿器用カテーテル","Ⅱ","34926012",0.484848,0.781579,0.0327869,{"medical_device_id":39,"generic_name":40,"class_classification":33,"jmdn_code":41,"name_similarity":42,"definition_similarity":24,"vector_similarity":43,"score":44},2083,"尿管カテーテル用アダプタ","31973000",0.390244,0.739586,0.032002,{"medical_device_id":46,"generic_name":47,"class_classification":33,"jmdn_code":48,"name_similarity":49,"definition_similarity":24,"vector_similarity":50,"score":51},2119,"再使用可能な尿管照明用カテーテル","41605000",0.388889,0.724563,0.0310245,{"medical_device_id":53,"generic_name":54,"class_classification":33,"jmdn_code":55,"name_similarity":56,"definition_similarity":24,"vector_similarity":57,"score":58},2000,"男性尿道造影向け泌尿器用カテーテル","32089000",0.267857,0.742822,0.0298277,{"medical_device_id":60,"generic_name":61,"class_classification":33,"jmdn_code":62,"name_similarity":63,"definition_similarity":24,"vector_similarity":64,"score":65},2143,"女性尿道造影向け泌尿器用カテーテル","70349000",0.275862,0.713844,0.0277831,{"medical_device_id":67,"generic_name":68,"class_classification":69,"jmdn_code":70,"name_similarity":71,"definition_similarity":24,"vector_similarity":72,"score":73},3659,"一時的使用金属製導尿用カテーテル","Ⅰ","70262000",0.258621,0.722183,0.0277459,{"medical_device_id":75,"generic_name":76,"class_classification":33,"jmdn_code":77,"name_similarity":78,"definition_similarity":24,"vector_similarity":79,"score":80},2005,"単回使用尿管照明用カテーテル","32035000",0.288136,0.708237,0.0275264,{"medical_device_id":82,"generic_name":83,"class_classification":33,"jmdn_code":84,"name_similarity":85,"definition_similarity":24,"vector_similarity":86,"score":87},2002,"尿管結石除去用チューブ及びカテーテル","70263000",0.245283,0.73179,0.0273897,{"medical_device_id":89,"generic_name":90,"class_classification":33,"jmdn_code":91,"name_similarity":92,"definition_similarity":24,"vector_similarity":93,"score":94},1987,"クデー泌尿器用カテーテル","31981000",0.26087,0.70789,0.0258161,{"medical_device_id":96,"generic_name":97,"class_classification":98,"jmdn_code":99,"name_similarity":100,"definition_similarity":24,"vector_similarity":101,"score":102},821,"腹膜透析用カテーテル","Ⅲ","34921000",0.24,0.704382,0.0234118,[104,108,112,116,120,124,128,131,134,138,142,146,150,153,156,159,162,165,168,171,174,177,180,183,186,189,192,195],{"product_code":105,"device_name":106,"device_class":8,"k510_count":107},"KOD","Catheter, Urological",238,{"product_code":109,"device_name":110,"device_class":8,"k510_count":111},"EZL","Catheter, Retention Type, Balloon",129,{"product_code":113,"device_name":114,"device_class":8,"k510_count":115},"EZD","Catheter, Straight",86,{"product_code":117,"device_name":118,"device_class":8,"k510_count":119},"GBM","Catheter, Urethral",71,{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"KNY","Accessories, Catheter, G-U",65,{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"FCM","Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)",60,{"product_code":129,"device_name":130,"device_class":8,"k510_count":27},"EYB","Catheter, Ureteral, Gastro-Urology",{"product_code":132,"device_name":133,"device_class":8,"k510_count":27},"LJH","System, Irrigation, Urological",{"product_code":135,"device_name":136,"device_class":8,"k510_count":137},"MJC","Catheter, Urological (Antimicrobial) And Accessories",10,{"product_code":139,"device_name":140,"device_class":8,"k510_count":141},"EZC","Catheter, Coude",7,{"product_code":143,"device_name":144,"device_class":8,"k510_count":145},"EYC","Catheter, Upper Urinary Tract",5,{"product_code":147,"device_name":148,"device_class":12,"k510_count":149},"EZB","Stylet For Catheter, Gastro-Urology",3,{"product_code":151,"device_name":152,"device_class":8,"k510_count":149},"FGI","Catheter, Urethrographic, Male",{"product_code":154,"device_name":155,"device_class":12,"k510_count":26},"EYK","Connector, Ureteral Catheter",{"product_code":157,"device_name":158,"device_class":8,"k510_count":26},"FGH","Catheter, Double Lumen Female Urethrographic",{"product_code":160,"device_name":161,"device_class":8,"k510_count":26},"NWO","Kit, Catheter, Urinary (Exludes Hiv Testing)",{"product_code":163,"device_name":164,"device_class":12,"k510_count":24},"EYA","Stylet, Ureteral",{"product_code":166,"device_name":167,"device_class":12,"k510_count":24},"EYI","Adaptor, Ureteral Catheter",{"product_code":169,"device_name":170,"device_class":12,"k510_count":24},"EYJ","Holder, Ureteral Catheter",{"product_code":172,"device_name":173,"device_class":19,"k510_count":24},"GBL","Catheter, Ureteral, General & Plastic Surgery",{"product_code":175,"device_name":176,"device_class":8,"k510_count":24},"OHR","Catheter Care Tray",{"product_code":178,"device_name":179,"device_class":8,"k510_count":24},"PPA","Bladder Irrigation Kit",{"product_code":181,"device_name":182,"device_class":8,"k510_count":24},"PPB","Foley Catheter Kit (Excludes Hiv Testing)",{"product_code":184,"device_name":185,"device_class":8,"k510_count":24},"PPC","Male External Catheterization Kit (Excludes Hiv Testing)",{"product_code":187,"device_name":188,"device_class":8,"k510_count":24},"PPD","Universal Drainage Tray",{"product_code":190,"device_name":191,"device_class":8,"k510_count":24},"PPF","Urinary Irrigation Kit",{"product_code":193,"device_name":194,"device_class":8,"k510_count":24},"PPG","Urinary Drainage Collection Kit",{"product_code":196,"device_name":197,"device_class":8,"k510_count":24},"SCT","Foley Catheters And Accessories With Additional Safety Features",{"510k":199,"classification":200,"enforcement":201,"event":202,"pma":203,"warning_letter":204},"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":206,"definition_ja":25,"commentary_ja":207,"model_name":208,"source_hash":209,"reviewed_by":25,"reviewed_at":25,"created_at":210,"updated_at":210},"使い捨てX線用尿管カテーテル","本機器は米国FDAの規制上クラスIIに分類されており、市販前届出（510(k)）の対象となる医療機器です。クラスIIは中程度のリスクを有する機器区分であり、既存の同等品（predicate device）との実質的同等性を示すことで市販が認められる制度です。","claude-sonnet-5","402cd39eb34839133b6213cbb0be67f45b9c0f708249432eb845d6cc40c7462c","2026-08-24T01:51:19.839721+00:00",{"product_code":6,"summary_ja":212,"stats":213,"stats_hash":225,"model_name":208,"created_at":226,"updated_at":226},"本製品区分は510(k)による市販前届出品目で、累計届出件数は1件、参入企業数は1社であり、直近5年間の届出実績はありません。不具合報告は累計約30件で、内訳は不具合(Malfunction)が最も多く、次いで傷害(Injury)の報告があり、死亡報告は0件となっています。直近5年間の報告はなく、最新の報告は2019年12月です。回収については累計0件で、該当する記録は確認されていません。",{"pma":214,"k510":215,"as_of":217,"events":218,"recalls":222,"top_problems":224},{"latest":25,"originals":24,"supplements":24},{"total":26,"last5y":24,"latest":216,"applicants":26},"1990-10-19","2026-08",{"death":24,"other":149,"total":27,"injury":219,"last5y":24,"malfunction":220,"latest_month":221},9,16,"2019-12",{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":223},[],[],"965dc62e76064e650896ce4dca82898a1390cfaa2eea9a860a7075f880387205","2026-08-24T04:21:40.396908+00:00",{"items":228,"total":24},[],{"items":230,"total":26},[231],{"k_number":18,"device_name":232,"applicant":233,"decision_date":216,"clearance_type":234,"decision_code":235,"statement_or_summary":25},"URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION","Applied Urology, Inc.","Traditional","SESE",{"items":237,"total":24},[]]