[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GBY":3},{"classification":4,"mappedDevices":43,"similarCandidates":44,"relatedClassifications":118,"syncDates":197},{"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":38,"updated_at":39,"recall_count":40,"latest_recall_date":41,"k510_count":40,"pma_count":40,"event_count":42},6163,"GBY","Catheter, Eustachian, General & Plastic Surgery","1","878.4200","SU","General, Plastic Surgery","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":36,"product_code":6,"review_panel":10,"gmp_exempt_flag":36,"third_party_flag":36,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":36,"medical_specialty_description":11,"summary_malfunction_reporting":37},{"fei_number":17,"registration_number":30},[18,19,20,21,22,23,24,25,26,27,28,29],"3021316061","3002750084","2916714","3002807421","3002806315","3006509795","3003418325","3043009869","3004216008","3016147813","3010131137","3023464160",[31,18,32,20,33,34,24,35,25,27,28,29],"1836161","9611827","8040278","9610612","8030607","N","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-18T22:05:38.961415+00:00",0,null,2,[],[45,53,60,67,75,82,89,96,103,110],{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":40,"vector_similarity":51,"score":52},2052,"耳管用カテーテル","Ⅱ","10718000",0.416667,0.773482,0.0325225,{"medical_device_id":54,"generic_name":55,"class_classification":48,"jmdn_code":56,"name_similarity":57,"definition_similarity":40,"vector_similarity":58,"score":59},2048,"汎用吸引用カテーテル","34923102",0.350877,0.675112,0.0305789,{"medical_device_id":61,"generic_name":62,"class_classification":48,"jmdn_code":63,"name_similarity":64,"definition_similarity":40,"vector_similarity":65,"score":66},1939,"気管支吸引用カテーテル","31249000",0.245614,0.673032,0.0283702,{"medical_device_id":68,"generic_name":69,"class_classification":70,"jmdn_code":71,"name_similarity":72,"definition_similarity":40,"vector_similarity":73,"score":74},680,"耳管用チューブ補綴材","Ⅲ","35512000",0.224138,0.697567,0.0279707,{"medical_device_id":76,"generic_name":77,"class_classification":48,"jmdn_code":78,"name_similarity":79,"definition_similarity":40,"vector_similarity":80,"score":81},2113,"気管支カテーテル","35673000",0.235294,0.668401,0.0274024,{"medical_device_id":83,"generic_name":84,"class_classification":70,"jmdn_code":85,"name_similarity":86,"definition_similarity":40,"vector_similarity":87,"score":88},413,"ウロキナーゼ使用汎用吸引用カテーテル","34923303",0.28169,0.655819,0.0271493,{"medical_device_id":90,"generic_name":91,"class_classification":70,"jmdn_code":92,"name_similarity":93,"definition_similarity":40,"vector_similarity":94,"score":95},1169,"耳管用補綴材","71083003",0.209677,0.678856,0.0262626,{"medical_device_id":97,"generic_name":98,"class_classification":48,"jmdn_code":99,"name_similarity":100,"definition_similarity":40,"vector_similarity":101,"score":102},1937,"気管吸引カテーテル","10749000",0.22807,0.663692,0.0256452,{"medical_device_id":104,"generic_name":105,"class_classification":70,"jmdn_code":106,"name_similarity":107,"definition_similarity":40,"vector_similarity":108,"score":109},1103,"気管支サーモプラスティ用カテーテルシステム","44775003",0.228571,0.654932,0.0243148,{"medical_device_id":111,"generic_name":112,"class_classification":113,"jmdn_code":114,"name_similarity":115,"definition_similarity":40,"vector_similarity":116,"score":117},3900,"一般外科・形成外科用鏡","Ⅰ","32261000",0.470588,0.565714,0.0163934,[119,123,127,131,135,139,143,147,151,154,157,161,164,168,172,175,178,182,185,188,191,194],{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"GBX","Catheter, Irrigation",77,{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"KGZ","Accessories, Catheter",29,{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"GBS","Catheter, Ventricular, General & Plastic Surgery",27,{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"GBZ","Catheter, Cholangiography",24,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"GBW","Catheter, Peritoneal",17,{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"JCY","Catheter, Infusion",14,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"GBO","Catheter, Nephrostomy, General & Plastic Surgery",11,{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"GBQ","Catheter, Continuous Irrigation",8,{"product_code":152,"device_name":153,"device_class":8,"k510_count":150},"GCB","Needle, Catheter",{"product_code":155,"device_name":156,"device_class":8,"k510_count":150},"GCD","Connector, Catheter",{"product_code":158,"device_name":159,"device_class":8,"k510_count":160},"GBA","Catheter, Balloon Type",5,{"product_code":162,"device_name":163,"device_class":8,"k510_count":160},"GCC","Dilator, Catheter",{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"GCE","Adaptor, Catheter",4,{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"GBP","Catheter, Multiple Lumen",3,{"product_code":173,"device_name":174,"device_class":8,"k510_count":42},"FGY","Cannula, Injection",{"product_code":176,"device_name":177,"device_class":8,"k510_count":42},"GBN","Catheter, Pediatric, General & Plastic Surgery",{"product_code":179,"device_name":180,"device_class":8,"k510_count":181},"OAJ","Catheter, Drainage, Intraoral\u002FExtraoral",1,{"product_code":183,"device_name":184,"device_class":8,"k510_count":40},"NMT","Needle, Catheter, Reprocessed",{"product_code":186,"device_name":187,"device_class":8,"k510_count":40},"PXU","Fluid Drainage Tray",{"product_code":189,"device_name":190,"device_class":8,"k510_count":40},"PYC","Paracentesis Tray",{"product_code":192,"device_name":193,"device_class":8,"k510_count":40},"PYG","Suction Catheter Kit",{"product_code":195,"device_name":196,"device_class":8,"k510_count":40},"PYI","Thoracic Catheter Insertion Tray",{"510k":198,"classification":199,"enforcement":200,"event":201,"pma":202,"warning_letter":203},"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"]