[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NML":3},{"classification":4,"mappedDevices":28,"similarCandidates":29,"relatedClassifications":112,"syncDates":132},{"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":23,"updated_at":24,"recall_count":25,"latest_recall_date":26,"k510_count":25,"pma_count":27,"event_count":25},701,"NML","Catheter, Biliary, Reprocessed","2","876.5010","GU","Gastroenterology, Urology","1","same as \"FGE\" except being reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https:\u002F\u002Fwww.govinfo.gov\u002Fcontent\u002Fpkg\u002FFR-2005-09-29\u002Fpdf\u002F05-19510.pdf).",false,{"openfda":16,"definition":13,"device_name":7,"review_code":19,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":10,"gmp_exempt_flag":20,"third_party_flag":21,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":19,"life_sustain_support_flag":20,"medical_specialty_description":11,"summary_malfunction_reporting":22},{"k_number":17},[18],"K012556","","N","Y","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-18T22:05:38.961415+00:00",1,null,0,[],[30,39,48,57,65,74,82,89,96,104],{"medical_device_id":31,"generic_name":32,"class_classification":33,"jmdn_code":34,"name_similarity":35,"definition_similarity":36,"vector_similarity":37,"score":38},1935,"胆道用カテーテル","Ⅱ","70245000",0.485714,0.0765766,0.688783,0.0322665,{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":45,"vector_similarity":46,"score":47},369,"長期的使用胆管用カテーテル","Ⅲ","10696013",0.404762,0.115079,0.691698,0.0315136,{"medical_device_id":49,"generic_name":50,"class_classification":51,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":56},1161,"再製造心臓用カテーテル型電極","Ⅳ","46359004",0.428571,0.162088,0.674502,0.0308349,{"medical_device_id":58,"generic_name":59,"class_classification":33,"jmdn_code":60,"name_similarity":61,"definition_similarity":62,"vector_similarity":63,"score":64},1925,"胆管向け圧測定用カテーテル","36181000",0.425,0.088785,0.663442,0.0297619,{"medical_device_id":66,"generic_name":67,"class_classification":68,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":73},3656,"耳鼻咽喉科用カテーテル","Ⅰ","16432001",0.275,0.16129,0.686494,0.0293236,{"medical_device_id":75,"generic_name":76,"class_classification":33,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},1922,"短期的使用胆管用カテーテル","10696022",0.395349,0.0984252,0.664391,0.029236,{"medical_device_id":83,"generic_name":84,"class_classification":33,"jmdn_code":85,"name_similarity":61,"definition_similarity":86,"vector_similarity":87,"score":88},1928,"胆管拡張用カテーテル","70239000",0.0490196,0.66082,0.0289583,{"medical_device_id":90,"generic_name":91,"class_classification":68,"jmdn_code":92,"name_similarity":70,"definition_similarity":93,"vector_similarity":94,"score":95},3839,"再使用可能な耳科用カテーテル","33395000",0.153571,0.684654,0.0287179,{"medical_device_id":97,"generic_name":98,"class_classification":33,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":103},1932,"バリウム注腸向け直腸用カテーテル","34912000",0.26087,0.11838,0.64831,0.0238129,{"medical_device_id":105,"generic_name":106,"class_classification":33,"jmdn_code":107,"name_similarity":108,"definition_similarity":109,"vector_similarity":110,"score":111},2054,"回腸瘻用直腸カテーテル","40099000",0.25,0.168459,0.641712,0.0228758,[113,117,121,125,129],{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"FGE","Stents, Drains And Dilators For The Biliary Ducts",476,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"LQR","Dislodger, Stone, Biliary",38,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"GCA","Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection",26,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"EXF","Bag, Bile Collecting",9,{"product_code":130,"device_name":131,"device_class":8,"k510_count":27},"PTT","Biliary Catheter For Irrigation And Contrast Injection, Exempt",{"510k":133,"classification":134,"enforcement":135,"event":136,"pma":137,"warning_letter":138},"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","2026-08-18T06:42:29.411+00:00"]