[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GCC":3},{"classification":4,"mappedDevices":165,"similarCandidates":166,"relatedClassifications":239,"syncDates":318},{"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":159,"updated_at":160,"recall_count":161,"latest_recall_date":162,"k510_count":161,"pma_count":163,"event_count":164},727,"GCC","Dilator, Catheter","1","878.4200","SU","General, Plastic Surgery","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":157,"product_code":6,"review_panel":10,"gmp_exempt_flag":157,"third_party_flag":157,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":157,"medical_specialty_description":11,"summary_malfunction_reporting":158},{"k_number":17,"fei_number":23,"registration_number":125},[18,19,20,21,22],"K893480","K981061","K902502","K820865","K922354",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124],"3374","1000393132","3429","3015489752","3015512299","1721504","3014620201","3006425876","3022320321","3004892425","3003094851","3003052153","3006142527","3004598675","3012267976","3005734757","1000555370","3003431869","3011642792","3039414397","2523865","3015895045","3002834291","3008808049","3009134882","3010071016","3013530345","1721676","3012995405","3006279007","3033589330","3002750084","3000335778","1000121056","3008770252","3007648354","3010138349","3007475226","1000136191","3004111573","3010011359","3009513193","3003644849","3015821396","3005747797","1000307733","3004216008","1000109483","3032747418","2124215","3010041511","3003221505","3005587147","3005813597","1820334","3015225571","1000517406","3035858921","3006509795","3005418651","3012226300","3021519357","3005304066","3005440795","3005528784","1417592","3004134316","3008853977","3000717902","3011499367","3004001706","3031231776","3008338766","3546","3012185136","3012536737","3002287318","3007878094","3003737899","1000123180","2522007","3002806816","1625425","3004215117","3002807214","3002809480","3027556548","3007773213","1828132","3005987240","3002807754","3006950086","3005099803","3008747867","2020550","1000115048","3010353847","3003032798","1000222207","3015309643","3005974802",[126,25,27,28,29,30,31,127,32,33,36,37,38,41,128,42,43,45,129,46,47,48,49,50,51,52,54,57,58,59,130,60,131,63,64,65,66,67,132,133,134,135,72,73,136,74,137,76,77,78,79,138,80,81,139,140,83,84,85,141,87,142,88,89,90,91,93,143,94,144,145,95,96,146,147,98,99,148,149,101,104,106,150,107,151,152,110,111,112,113,153,115,116,154,118,155,120,121,123,156,124],"8043752","8040263","9681161","9616246","2134285","9617744","9710058","8040278","1058020","2431166","8040881","1123137","1058726","9613079","9680794","9612075","1836161","8043816","9611283","3011137372","8040884","9680518","8010704","1421879","2133928","1724474","3010202439","2529846","9616662","8030607","3005067367","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-18T22:05:38.961415+00:00",5,"2013-11-06",0,72,[],[167,175,183,190,197,205,212,219,226,233],{"medical_device_id":168,"generic_name":169,"class_classification":170,"jmdn_code":171,"name_similarity":172,"definition_similarity":163,"vector_similarity":173,"score":174},2904,"カテーテル拡張器","Ⅱ","32338000",0.85,0.860642,0.0327869,{"medical_device_id":176,"generic_name":177,"class_classification":178,"jmdn_code":179,"name_similarity":180,"definition_similarity":163,"vector_similarity":181,"score":182},4355,"拡張器","Ⅰ","11254000",0.470588,0.816677,0.031746,{"medical_device_id":184,"generic_name":185,"class_classification":170,"jmdn_code":186,"name_similarity":187,"definition_similarity":163,"vector_similarity":188,"score":189},1928,"胆管拡張用カテーテル","70239000",0.451613,0.791117,0.0310096,{"medical_device_id":191,"generic_name":192,"class_classification":170,"jmdn_code":193,"name_similarity":194,"definition_similarity":163,"vector_similarity":195,"score":196},1936,"内視鏡下拡張用カテーテル","70246000",0.4375,0.786208,0.030303,{"medical_device_id":198,"generic_name":199,"class_classification":200,"jmdn_code":201,"name_similarity":202,"definition_similarity":163,"vector_similarity":203,"score":204},55,"サーモダイリューション用カテーテル","Ⅳ","34925100",0.4,0.782095,0.0291986,{"medical_device_id":206,"generic_name":207,"class_classification":178,"jmdn_code":208,"name_similarity":209,"definition_similarity":163,"vector_similarity":210,"score":211},3710,"子宮頚管拡張器","70344000",0.36,0.818808,0.0289495,{"medical_device_id":213,"generic_name":214,"class_classification":170,"jmdn_code":215,"name_similarity":216,"definition_similarity":163,"vector_similarity":217,"score":218},2051,"デペーゼカテーテル","10709000",0.416667,0.764892,0.0280833,{"medical_device_id":220,"generic_name":221,"class_classification":170,"jmdn_code":222,"name_similarity":223,"definition_similarity":163,"vector_similarity":224,"score":225},1989,"尿管向け泌尿器用カテーテル","34926012",0.375,0.76774,0.0270468,{"medical_device_id":227,"generic_name":228,"class_classification":170,"jmdn_code":229,"name_similarity":230,"definition_similarity":163,"vector_similarity":231,"score":232},2067,"注入用カテーテル","33172000",0.346154,0.777257,0.0263339,{"medical_device_id":234,"generic_name":235,"class_classification":170,"jmdn_code":236,"name_similarity":223,"definition_similarity":163,"vector_similarity":237,"score":238},2053,"直腸用カテーテル","10746000",0.759641,0.0254183,[240,244,248,252,256,260,264,268,272,275,278,281,285,289,293,296,300,303,306,309,312,315],{"product_code":241,"device_name":242,"device_class":8,"k510_count":243},"GBX","Catheter, Irrigation",77,{"product_code":245,"device_name":246,"device_class":8,"k510_count":247},"KGZ","Accessories, Catheter",29,{"product_code":249,"device_name":250,"device_class":8,"k510_count":251},"GBS","Catheter, Ventricular, General & Plastic Surgery",27,{"product_code":253,"device_name":254,"device_class":8,"k510_count":255},"GBZ","Catheter, Cholangiography",24,{"product_code":257,"device_name":258,"device_class":8,"k510_count":259},"GBW","Catheter, Peritoneal",17,{"product_code":261,"device_name":262,"device_class":8,"k510_count":263},"JCY","Catheter, Infusion",14,{"product_code":265,"device_name":266,"device_class":8,"k510_count":267},"GBO","Catheter, Nephrostomy, General & Plastic Surgery",11,{"product_code":269,"device_name":270,"device_class":8,"k510_count":271},"GBQ","Catheter, Continuous Irrigation",8,{"product_code":273,"device_name":274,"device_class":8,"k510_count":271},"GCB","Needle, Catheter",{"product_code":276,"device_name":277,"device_class":8,"k510_count":271},"GCD","Connector, Catheter",{"product_code":279,"device_name":280,"device_class":8,"k510_count":161},"GBA","Catheter, Balloon Type",{"product_code":282,"device_name":283,"device_class":8,"k510_count":284},"GCE","Adaptor, Catheter",4,{"product_code":286,"device_name":287,"device_class":8,"k510_count":288},"GBP","Catheter, Multiple Lumen",3,{"product_code":290,"device_name":291,"device_class":8,"k510_count":292},"FGY","Cannula, Injection",2,{"product_code":294,"device_name":295,"device_class":8,"k510_count":292},"GBN","Catheter, Pediatric, General & Plastic Surgery",{"product_code":297,"device_name":298,"device_class":8,"k510_count":299},"OAJ","Catheter, Drainage, Intraoral\u002FExtraoral",1,{"product_code":301,"device_name":302,"device_class":8,"k510_count":163},"GBY","Catheter, Eustachian, General & Plastic Surgery",{"product_code":304,"device_name":305,"device_class":8,"k510_count":163},"NMT","Needle, Catheter, Reprocessed",{"product_code":307,"device_name":308,"device_class":8,"k510_count":163},"PXU","Fluid Drainage Tray",{"product_code":310,"device_name":311,"device_class":8,"k510_count":163},"PYC","Paracentesis Tray",{"product_code":313,"device_name":314,"device_class":8,"k510_count":163},"PYG","Suction Catheter Kit",{"product_code":316,"device_name":317,"device_class":8,"k510_count":163},"PYI","Thoracic Catheter Insertion Tray",{"510k":319,"classification":320,"enforcement":321,"event":322,"pma":323,"warning_letter":324},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]