[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NGU":3},{"classification":4,"mappedDevices":28,"similarCandidates":29,"relatedClassifications":101,"syncDates":247,"translation":254,"marketSummary":260,"recalls":273,"k510s":275,"pmas":283},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":23,"updated_at":24,"recall_count":25,"latest_recall_date":26,"k510_count":27,"pma_count":25,"event_count":25},2379,"NGU","Balloon, Liver Tamponade","2","876.5980","GU","Gastroenterology, Urology","SU","1","",false,{"openfda":17,"definition":14,"device_name":7,"review_code":14,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":12,"gmp_exempt_flag":20,"third_party_flag":21,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":14,"life_sustain_support_flag":20,"medical_specialty_description":11,"summary_malfunction_reporting":22},{"k_number":18},[19],"K010450","N","Y","Eligible","2026-08-18T05:52:49.993647+00:00","2026-08-24T02:00:47.949024+00:00",0,null,1,[],[30,38,46,52,59,66,72,80,87,94],{"medical_device_id":31,"generic_name":32,"class_classification":33,"jmdn_code":34,"name_similarity":35,"definition_similarity":25,"vector_similarity":36,"score":37},3655,"鼻腔内用バルーン","Ⅰ","12699000",0.266667,0.650081,0.0308349,{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":25,"vector_similarity":44,"score":45},1919,"腸管用バルーンカテーテル","Ⅱ","70237000",0.209302,0.657778,0.0297095,{"medical_device_id":47,"generic_name":48,"class_classification":33,"jmdn_code":49,"name_similarity":43,"definition_similarity":25,"vector_similarity":50,"score":51},3648,"食道用バルーンカテーテル","34915000",0.654971,0.0294372,{"medical_device_id":53,"generic_name":54,"class_classification":33,"jmdn_code":55,"name_similarity":56,"definition_similarity":25,"vector_similarity":57,"score":58},3469,"超音波用バルーン","70168000",0.228571,0.636771,0.0293236,{"medical_device_id":60,"generic_name":61,"class_classification":41,"jmdn_code":62,"name_similarity":63,"definition_similarity":25,"vector_similarity":64,"score":65},2099,"子宮用バルーン","12155000",0.216216,0.643645,0.0291986,{"medical_device_id":67,"generic_name":68,"class_classification":41,"jmdn_code":69,"name_similarity":43,"definition_similarity":25,"vector_similarity":70,"score":71},2019,"圧測定用バルーン型カテーテル","17745000",0.639545,0.0287785,{"medical_device_id":73,"generic_name":74,"class_classification":75,"jmdn_code":76,"name_similarity":77,"definition_similarity":25,"vector_similarity":78,"score":79},100,"リトラクトバルーン","Ⅳ","70294000",0.222222,0.636508,0.028665,{"medical_device_id":81,"generic_name":82,"class_classification":41,"jmdn_code":83,"name_similarity":84,"definition_similarity":25,"vector_similarity":85,"score":86},2102,"直腸括約筋バルーン","17781000",0.195122,0.665426,0.028373,{"medical_device_id":88,"generic_name":89,"class_classification":41,"jmdn_code":90,"name_similarity":91,"definition_similarity":25,"vector_similarity":92,"score":93},1970,"気管支バルーンカテーテル","17827000",0.219512,0.628442,0.0279124,{"medical_device_id":95,"generic_name":96,"class_classification":33,"jmdn_code":97,"name_similarity":98,"definition_similarity":25,"vector_similarity":99,"score":100},3437,"内視鏡用バルーンポンプ","36500001",0.2,0.650369,0.0277459,[102,106,110,114,118,122,126,130,134,137,141,145,149,152,155,158,162,165,168,171,174,177,180,183,186,189,192,195,198,201,204,207,210,213,216,219,222,225,228,231,234,237,240,243],{"product_code":103,"device_name":104,"device_class":8,"k510_count":105},"KNT","Tubes, Gastrointestinal (And Accessories)",650,{"product_code":107,"device_name":108,"device_class":8,"k510_count":109},"FPD","Tube, Feeding",59,{"product_code":111,"device_name":112,"device_class":8,"k510_count":113},"PIF","Gastrointestinal Tubes With Enteral Specific Connectors",50,{"product_code":115,"device_name":116,"device_class":8,"k510_count":117},"PNR","Enteral Syringes With Enteral Specific Connectors",34,{"product_code":119,"device_name":120,"device_class":8,"k510_count":121},"KGC","Tube, Gastro-Enterostomy",26,{"product_code":123,"device_name":124,"device_class":8,"k510_count":125},"KDH","Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration",23,{"product_code":127,"device_name":128,"device_class":8,"k510_count":129},"EYN","Tray, Irrigation, Sterile",15,{"product_code":131,"device_name":132,"device_class":8,"k510_count":133},"BSS","Tube, Nasogastric",13,{"product_code":135,"device_name":136,"device_class":8,"k510_count":133},"FEG","Tube, Double Lumen For Intestinal Decompression And\u002FOr Intubation",{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"PIO","Enteral Specific Transition Connectors",9,{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"FGD","Catheter, Retention, Barium Enema With Bag",6,{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"EZK","Catheter, Retention Type",3,{"product_code":150,"device_name":151,"device_class":8,"k510_count":148},"FRQ","Tube, Levine",{"product_code":153,"device_name":154,"device_class":8,"k510_count":148},"GBT","Catheter, Rectal",{"product_code":156,"device_name":157,"device_class":8,"k510_count":148},"PID","Esophageal Dilator Balloon With Or Without Electrode Sensors",{"product_code":159,"device_name":160,"device_class":8,"k510_count":161},"PBP","Rectal Insert",2,{"product_code":163,"device_name":164,"device_class":8,"k510_count":161},"PIE","Esophageal Dilator With Balloon And Electrode Sensors",{"product_code":166,"device_name":167,"device_class":8,"k510_count":27},"FEF","Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And \u002F Or Decompression",{"product_code":169,"device_name":170,"device_class":8,"k510_count":27},"FHT","Set, Gavage, Infant, Sterile",{"product_code":172,"device_name":173,"device_class":8,"k510_count":27},"LEY","Set, Oral Administration",{"product_code":175,"device_name":176,"device_class":8,"k510_count":27},"PLI","Gastrointestional Tube Holder",{"product_code":178,"device_name":179,"device_class":8,"k510_count":25},"FCB","Bag, Hemostatic",{"product_code":181,"device_name":182,"device_class":8,"k510_count":25},"FFW","String And Tubes, Gastrointestinal, To Locate Internal Bleeding",{"product_code":184,"device_name":185,"device_class":8,"k510_count":25},"LCG","Intestinal Splinting Tubes",{"product_code":187,"device_name":188,"device_class":8,"k510_count":25},"PRM","Enteral Administration Kit (Adult & Pediatric)",{"product_code":190,"device_name":191,"device_class":8,"k510_count":25},"PRP","Balloon Gastrostomy Tube Kit",{"product_code":193,"device_name":194,"device_class":8,"k510_count":25},"PRR","Feeding Tube Kit",{"product_code":196,"device_name":197,"device_class":8,"k510_count":25},"PRS","Gastric Colonic Catheter Irrigation Kit",{"product_code":199,"device_name":200,"device_class":8,"k510_count":25},"PRT","Gastric Irrigation And Aspiration Kit",{"product_code":202,"device_name":203,"device_class":8,"k510_count":25},"PRW","Gastrointestinal Tube Kit",{"product_code":205,"device_name":206,"device_class":8,"k510_count":25},"PRX","Gastrostomy Guide Wire Placement Kit",{"product_code":208,"device_name":209,"device_class":8,"k510_count":25},"PRY","Gastrostomy Jejunostomy Feeding Tube Kit",{"product_code":211,"device_name":212,"device_class":8,"k510_count":25},"PRZ","Gastrostomy Tube Kit",{"product_code":214,"device_name":215,"device_class":8,"k510_count":25},"PSA","Laparoscopic Jejunostomy Kit",{"product_code":217,"device_name":218,"device_class":8,"k510_count":25},"PSB","Nasogastric Feed Tube Kit",{"product_code":220,"device_name":221,"device_class":8,"k510_count":25},"PSC","Nasogastric-Gastrojejunal Kit",{"product_code":223,"device_name":224,"device_class":8,"k510_count":25},"PSD","Laparoscopic Gastrostomy Kit",{"product_code":226,"device_name":227,"device_class":8,"k510_count":25},"PSE","Needle Catheter Jejunostomy Kit",{"product_code":229,"device_name":230,"device_class":8,"k510_count":25},"PSF","Non-Balloon Replacement Gastrostomy System",{"product_code":232,"device_name":233,"device_class":8,"k510_count":25},"PSG","Percutaneous Endoscopic Gastrostomy Kit",{"product_code":235,"device_name":236,"device_class":8,"k510_count":25},"PSH","Percutaneous Replacement Gastrostomy Tube Kit",{"product_code":238,"device_name":239,"device_class":8,"k510_count":25},"PSI","Perineal Irrigation Kit",{"product_code":241,"device_name":242,"device_class":8,"k510_count":25},"PSK","Replacement Gastrostomy Feeding Catheter Tray",{"product_code":244,"device_name":245,"device_class":246,"k510_count":25},"PTK","Pediatric Esophageal Atresia Anastomosis Device","3",{"510k":248,"classification":249,"enforcement":250,"event":251,"pma":252,"warning_letter":253},"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":255,"definition_ja":26,"commentary_ja":256,"model_name":257,"source_hash":258,"reviewed_by":26,"reviewed_at":26,"created_at":259,"updated_at":259},"肝タンポナーデ用バルーン","本品は米国FDAの分類においてクラスIIに区分される医療機器であり、市販前届出（510(k)）による審査を経て市場に流通することが求められます。510(k)は、既存の同等品（実質的同等性）との比較に基づいて安全性・有効性を確認する審査区分であり、クラスIIIに適用される市販前承認（PMA）に比べて簡略化された手続きとなっています。","claude-sonnet-5","ba21dda2ec969a22ce9da887d68639f44b93becc10dc8104cfff39602e801892","2026-08-24T02:15:50.744711+00:00",{"product_code":6,"summary_ja":261,"stats":262,"stats_hash":271,"model_name":257,"created_at":272,"updated_at":272},"本製品分野の510(k)は累計1件で、参入企業は1社にとどまり、直近5年間の届出は確認されていません。不具合報告および回収について、いずれも報告・実施例は確認されていません。",{"pma":263,"k510":264,"as_of":266,"events":267,"recalls":268,"top_problems":270},{"latest":26,"originals":25,"supplements":25},{"total":27,"last5y":25,"latest":265,"applicants":27},"2001-09-06","2026-08",{"death":25,"other":25,"total":25,"injury":25,"last5y":25,"malfunction":25,"latest_month":26},{"total":25,"last5y":25,"latest":26,"class_i":25,"class_ii":25,"class_iii":25,"top_root_causes":269},[],[],"9a87c257f5d4a009c6f1f533bf535e5dce50009dccceedfb44d2d17e62d022ce","2026-08-24T04:59:09.208125+00:00",{"items":274,"total":25},[],{"items":276,"total":27},[277],{"k_number":19,"device_name":278,"applicant":279,"decision_date":265,"clearance_type":280,"decision_code":281,"statement_or_summary":282},"LIVER TAMPONADE BALLOON","Cook, Inc.","Traditional","SESE","Summary",{"items":284,"total":25},[]]