[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FGD":3},{"classification":4,"mappedDevices":50,"similarCandidates":51,"relatedClassifications":124,"syncDates":270},{"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":44,"updated_at":45,"recall_count":46,"latest_recall_date":47,"k510_count":48,"pma_count":46,"event_count":49},5322,"FGD","Catheter, Retention, Barium Enema With Bag","2","876.5980","GU","Gastroenterology, Urology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":42,"product_code":6,"review_panel":10,"gmp_exempt_flag":42,"third_party_flag":42,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":42,"medical_specialty_description":11,"summary_malfunction_reporting":43},{"k_number":17,"fei_number":24,"registration_number":40},[18,19,20,21,22,23],"K223890","K905026","K904299","K872006","K884379","K905574",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"2411512","3011752740","3008496560","3006210673","3045058049","3010339057","1417592","3010547268","3016872092","3010291427","3005099803","3002807391","3038190598","3025337868","3006536657",[25,26,27,41,28,29,30,31,32,33,34,35,37,38,39],"9610849","N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",0,null,6,25,[],[52,60,67,75,82,89,96,104,110,117],{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":46,"vector_similarity":58,"score":59},1932,"バリウム注腸向け直腸用カテーテル","Ⅱ","34912000",0.55814,0.757167,0.0327869,{"medical_device_id":61,"generic_name":62,"class_classification":55,"jmdn_code":63,"name_similarity":64,"definition_similarity":46,"vector_similarity":65,"score":66},1915,"バリウム用浣腸キット","16514000",0.309524,0.71633,0.031746,{"medical_device_id":68,"generic_name":69,"class_classification":70,"jmdn_code":71,"name_similarity":72,"definition_similarity":46,"vector_similarity":73,"score":74},3656,"耳鼻咽喉科用カテーテル","Ⅰ","16432001",0.304348,0.676719,0.0297095,{"medical_device_id":76,"generic_name":77,"class_classification":55,"jmdn_code":78,"name_similarity":79,"definition_similarity":46,"vector_similarity":80,"score":81},2064,"創部用吸引留置カテーテル","70307000",0.270833,0.672021,0.0282587,{"medical_device_id":83,"generic_name":84,"class_classification":55,"jmdn_code":85,"name_similarity":86,"definition_similarity":46,"vector_similarity":87,"score":88},2039,"血管縫合用内腔維持カテーテル","70291000",0.3,0.661849,0.0272894,{"medical_device_id":90,"generic_name":91,"class_classification":55,"jmdn_code":92,"name_similarity":93,"definition_similarity":46,"vector_similarity":94,"score":95},1361,"バリウム注腸用造影剤注入・排泄キット","40725000",0.239437,0.711984,0.0271193,{"medical_device_id":97,"generic_name":98,"class_classification":99,"jmdn_code":100,"name_similarity":101,"definition_similarity":46,"vector_similarity":102,"score":103},110,"オキシメトリー用バルーン付カテーテル","Ⅳ","35856100",0.326923,0.58894,0.016129,{"medical_device_id":105,"generic_name":106,"class_classification":55,"jmdn_code":107,"name_similarity":108,"definition_similarity":46,"vector_similarity":109,"score":103},2210,"単回使用手動式バリウム注腸用造影剤注入・排泄キット","70403000",0.171717,0.73355,{"medical_device_id":111,"generic_name":112,"class_classification":55,"jmdn_code":113,"name_similarity":114,"definition_similarity":46,"vector_similarity":115,"score":116},2066,"短期的使用アンブレラカテーテル","10760002",0.15,0.709341,0.0153846,{"medical_device_id":118,"generic_name":119,"class_classification":99,"jmdn_code":120,"name_similarity":121,"definition_similarity":46,"vector_similarity":122,"score":123},111,"ヘパリン使用オキシメトリー用バルーン付カテーテル","35856200",0.276923,0.584207,0.0151515,[125,129,133,137,141,145,149,153,157,160,164,168,171,174,177,181,184,188,191,194,197,200,203,206,209,212,215,218,221,224,227,230,233,236,239,242,245,248,251,254,257,260,263,266],{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"KNT","Tubes, Gastrointestinal (And Accessories)",650,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"FPD","Tube, Feeding",59,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"PIF","Gastrointestinal Tubes With Enteral Specific Connectors",50,{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"PNR","Enteral Syringes With Enteral Specific Connectors",34,{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"KGC","Tube, Gastro-Enterostomy",26,{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"KDH","Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration",23,{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"EYN","Tray, Irrigation, Sterile",15,{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"BSS","Tube, Nasogastric",13,{"product_code":158,"device_name":159,"device_class":8,"k510_count":156},"FEG","Tube, Double Lumen For Intestinal Decompression And\u002FOr Intubation",{"product_code":161,"device_name":162,"device_class":8,"k510_count":163},"PIO","Enteral Specific Transition Connectors",9,{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"EZK","Catheter, Retention Type",3,{"product_code":169,"device_name":170,"device_class":8,"k510_count":167},"FRQ","Tube, Levine",{"product_code":172,"device_name":173,"device_class":8,"k510_count":167},"GBT","Catheter, Rectal",{"product_code":175,"device_name":176,"device_class":8,"k510_count":167},"PID","Esophageal Dilator Balloon With Or Without Electrode Sensors",{"product_code":178,"device_name":179,"device_class":8,"k510_count":180},"PBP","Rectal Insert",2,{"product_code":182,"device_name":183,"device_class":8,"k510_count":180},"PIE","Esophageal Dilator With Balloon And Electrode Sensors",{"product_code":185,"device_name":186,"device_class":8,"k510_count":187},"FEF","Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And \u002F Or Decompression",1,{"product_code":189,"device_name":190,"device_class":8,"k510_count":187},"FHT","Set, Gavage, Infant, Sterile",{"product_code":192,"device_name":193,"device_class":8,"k510_count":187},"LEY","Set, Oral Administration",{"product_code":195,"device_name":196,"device_class":8,"k510_count":187},"NGU","Balloon, Liver Tamponade",{"product_code":198,"device_name":199,"device_class":8,"k510_count":187},"PLI","Gastrointestional Tube Holder",{"product_code":201,"device_name":202,"device_class":8,"k510_count":46},"FCB","Bag, Hemostatic",{"product_code":204,"device_name":205,"device_class":8,"k510_count":46},"FFW","String And Tubes, Gastrointestinal, To Locate Internal Bleeding",{"product_code":207,"device_name":208,"device_class":8,"k510_count":46},"LCG","Intestinal Splinting Tubes",{"product_code":210,"device_name":211,"device_class":8,"k510_count":46},"PRM","Enteral Administration Kit (Adult & Pediatric)",{"product_code":213,"device_name":214,"device_class":8,"k510_count":46},"PRP","Balloon Gastrostomy Tube Kit",{"product_code":216,"device_name":217,"device_class":8,"k510_count":46},"PRR","Feeding Tube Kit",{"product_code":219,"device_name":220,"device_class":8,"k510_count":46},"PRS","Gastric Colonic Catheter Irrigation Kit",{"product_code":222,"device_name":223,"device_class":8,"k510_count":46},"PRT","Gastric Irrigation And Aspiration Kit",{"product_code":225,"device_name":226,"device_class":8,"k510_count":46},"PRW","Gastrointestinal Tube Kit",{"product_code":228,"device_name":229,"device_class":8,"k510_count":46},"PRX","Gastrostomy Guide Wire Placement Kit",{"product_code":231,"device_name":232,"device_class":8,"k510_count":46},"PRY","Gastrostomy Jejunostomy Feeding Tube Kit",{"product_code":234,"device_name":235,"device_class":8,"k510_count":46},"PRZ","Gastrostomy Tube Kit",{"product_code":237,"device_name":238,"device_class":8,"k510_count":46},"PSA","Laparoscopic Jejunostomy Kit",{"product_code":240,"device_name":241,"device_class":8,"k510_count":46},"PSB","Nasogastric Feed Tube Kit",{"product_code":243,"device_name":244,"device_class":8,"k510_count":46},"PSC","Nasogastric-Gastrojejunal Kit",{"product_code":246,"device_name":247,"device_class":8,"k510_count":46},"PSD","Laparoscopic Gastrostomy Kit",{"product_code":249,"device_name":250,"device_class":8,"k510_count":46},"PSE","Needle Catheter Jejunostomy Kit",{"product_code":252,"device_name":253,"device_class":8,"k510_count":46},"PSF","Non-Balloon Replacement Gastrostomy System",{"product_code":255,"device_name":256,"device_class":8,"k510_count":46},"PSG","Percutaneous Endoscopic Gastrostomy Kit",{"product_code":258,"device_name":259,"device_class":8,"k510_count":46},"PSH","Percutaneous Replacement Gastrostomy Tube Kit",{"product_code":261,"device_name":262,"device_class":8,"k510_count":46},"PSI","Perineal Irrigation Kit",{"product_code":264,"device_name":265,"device_class":8,"k510_count":46},"PSK","Replacement Gastrostomy Feeding Catheter Tray",{"product_code":267,"device_name":268,"device_class":269,"k510_count":46},"PTK","Pediatric Esophageal Atresia Anastomosis Device","3",{"510k":271,"classification":272,"enforcement":273,"event":274,"pma":275,"warning_letter":276},"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"]