FDA.reportPublic FDA data

ERCP catheter, non-balloon, electrosurgical

Definition
A flexible, tubular device designed to be inserted into the duodenum via the oral cavity (cannulation) using a flexible endoscope to: 1) infuse contrast media; and 2) deliver electrosurgical current in a monopolar configuration to cut the major duodenal papilla (papillotomy) and approximate tissues, during endoscopic retrograde cholangiopancreatography (ERCP). It includes proximal controls, a distal monopolar electrosurgical cutting wire and an inner lumen(s); it does not incorporate a balloon. This is a single-use device.
GUDID devices
131
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06934415023498ZKSKBeijing ZKSK Technology Co.,LtdECK18-25-05-2302026-05-15
06934415023504ZKSKBeijing ZKSK Technology Co.,LtdECK18-20-05-2302026-05-15
06934415023511ZKSKBeijing ZKSK Technology Co.,LtdECK18-25-05-2002026-05-15
06934415023528ZKSKBeijing ZKSK Technology Co.,LtdECK18-25-10-2002026-05-15
06934415023535ZKSKBeijing ZKSK Technology Co.,LtdECK18-30-05-2002026-05-15
06934415023993ZKSKBeijing ZKSK Technology Co.,LtdECK18-20-05-1802026-05-15
06934415024006ZKSKBeijing ZKSK Technology Co.,LtdECK18-10-05-1802026-05-15
06934415024013ZKSKBeijing ZKSK Technology Co.,LtdECK18-10-05-2002026-05-15
06934415024020ZKSKBeijing ZKSK Technology Co.,LtdECK18-10-05-2302026-05-15
06934415024037ZKSKBeijing ZKSK Technology Co.,LtdECK18-10-10-1802026-05-15
06934415024044ZKSKBeijing ZKSK Technology Co.,LtdECK18-10-10-2002026-05-15
06934415024051ZKSKBeijing ZKSK Technology Co.,LtdECK18-10-10-2302026-05-15
06934415024068ZKSKBeijing ZKSK Technology Co.,LtdECK18-10-15-1802026-05-15
06934415024075ZKSKBeijing ZKSK Technology Co.,LtdECK18-10-15-2002026-05-15
06934415024082ZKSKBeijing ZKSK Technology Co.,LtdECK18-10-15-2302026-05-15
06934415024099ZKSKBeijing ZKSK Technology Co.,LtdECK18-20-05-2002026-05-15
06934415024105ZKSKBeijing ZKSK Technology Co.,LtdECK18-20-10-1802026-05-15
06934415024112ZKSKBeijing ZKSK Technology Co.,LtdECK18-20-10-2002026-05-15
06934415024129ZKSKBeijing ZKSK Technology Co.,LtdECK18-20-10-2302026-05-15
06934415024136ZKSKBeijing ZKSK Technology Co.,LtdECK18-20-15-1802026-05-15
06934415024143ZKSKBeijing ZKSK Technology Co.,LtdECK18-20-15-2002026-05-15
06934415024150ZKSKBeijing ZKSK Technology Co.,LtdECK18-20-15-2302026-05-15
06934415024167ZKSKBeijing ZKSK Technology Co.,LtdECK18-25-05-1802026-05-15
06934415024174ZKSKBeijing ZKSK Technology Co.,LtdECK18-25-10-1802026-05-15
06934415024181ZKSKBeijing ZKSK Technology Co.,LtdECK18-25-10-2302026-05-15
06934415024198ZKSKBeijing ZKSK Technology Co.,LtdECK18-25-15-1802026-05-15
06934415024204ZKSKBeijing ZKSK Technology Co.,LtdECK18-25-15-2002026-05-15
06934415024211ZKSKBeijing ZKSK Technology Co.,LtdECK18-25-15-2302026-05-15
06934415024228ZKSKBeijing ZKSK Technology Co.,LtdECK18-30-05-1802026-05-15
06934415024235ZKSKBeijing ZKSK Technology Co.,LtdECK18-30-10-1802026-05-15
06934415024242ZKSKBeijing ZKSK Technology Co.,LtdECK18-30-10-2002026-05-15
06934415024259ZKSKBeijing ZKSK Technology Co.,LtdECK18-30-10-2302026-05-15
06934415024266ZKSKBeijing ZKSK Technology Co.,LtdECK18-30-15-1802026-05-15
06934415024273ZKSKBeijing ZKSK Technology Co.,LtdECK18-30-15-2002026-05-15
06934415024280ZKSKBeijing ZKSK Technology Co.,LtdECK18-30-15-2302026-05-15
06934415024297ZKSKBeijing ZKSK Technology Co.,LtdECK19-10-05-1802026-05-15
06934415024303ZKSKBeijing ZKSK Technology Co.,LtdECK19-10-05-2002026-05-15
06934415024310ZKSKBeijing ZKSK Technology Co.,LtdECK19-10-05-2302026-05-15
06934415024327ZKSKBeijing ZKSK Technology Co.,LtdECK19-10-10-1802026-05-15
06934415024334ZKSKBeijing ZKSK Technology Co.,LtdECK19-10-10-2002026-05-15
06934415024341ZKSKBeijing ZKSK Technology Co.,LtdECK19-10-10-2302026-05-15
06934415024358ZKSKBeijing ZKSK Technology Co.,LtdECK19-10-15-1802026-05-15
06934415024365ZKSKBeijing ZKSK Technology Co.,LtdECK19-10-15-2002026-05-15
06934415024372ZKSKBeijing ZKSK Technology Co.,LtdECK19-10-15-2302026-05-15
06934415024389ZKSKBeijing ZKSK Technology Co.,LtdECK19-20-05-1802026-05-15
06934415024396ZKSKBeijing ZKSK Technology Co.,LtdECK19-20-05-2002026-05-15
06934415024402ZKSKBeijing ZKSK Technology Co.,LtdECK19-20-05-2302026-05-15
06934415024419ZKSKBeijing ZKSK Technology Co.,LtdECK19-20-10-1802026-05-15
06934415024426ZKSKBeijing ZKSK Technology Co.,LtdECK19-20-10-2002026-05-15
06934415024433ZKSKBeijing ZKSK Technology Co.,LtdECK19-20-10-2302026-05-15
06934415024440ZKSKBeijing ZKSK Technology Co.,LtdECK19-20-15-1802026-05-15
06934415024457ZKSKBeijing ZKSK Technology Co.,LtdECK19-20-15-2002026-05-15
06934415024464ZKSKBeijing ZKSK Technology Co.,LtdECK19-20-15-2302026-05-15
06934415024471ZKSKBeijing ZKSK Technology Co.,LtdECK19-25-05-1802026-05-15
06934415024488ZKSKBeijing ZKSK Technology Co.,LtdECK19-25-05-2002026-05-15
06934415024495ZKSKBeijing ZKSK Technology Co.,LtdECK19-25-05-2302026-05-15
06934415024501ZKSKBeijing ZKSK Technology Co.,LtdECK19-25-10-1802026-05-15
06934415024518ZKSKBeijing ZKSK Technology Co.,LtdECK19-25-10-2002026-05-15
06934415024525ZKSKBeijing ZKSK Technology Co.,LtdECK19-25-10-2302026-05-15
06934415024532ZKSKBeijing ZKSK Technology Co.,LtdECK19-25-15-1802026-05-15
06934415024549ZKSKBeijing ZKSK Technology Co.,LtdECK19-25-15-2002026-05-15
06934415024556ZKSKBeijing ZKSK Technology Co.,LtdECK19-25-15-2302026-05-15
06934415024563ZKSKBeijing ZKSK Technology Co.,LtdECK19-30-05-1802026-05-15
06934415024570ZKSKBeijing ZKSK Technology Co.,LtdECK19-30-05-2002026-05-15
06934415024587ZKSKBeijing ZKSK Technology Co.,LtdECK19-30-05-2302026-05-15
06934415024594ZKSKBeijing ZKSK Technology Co.,LtdECK19-30-10-1802026-05-15
06934415024600ZKSKBeijing ZKSK Technology Co.,LtdECK19-30-10-2002026-05-15
06934415024617ZKSKBeijing ZKSK Technology Co.,LtdECK19-30-10-2302026-05-15
06934415024624ZKSKBeijing ZKSK Technology Co.,LtdECK19-30-15-1802026-05-15
06934415024631ZKSKBeijing ZKSK Technology Co.,LtdECK19-30-15-2002026-05-15
06934415024648ZKSKBeijing ZKSK Technology Co.,LtdECK19-30-15-2302026-05-15
06934415068604ZKSKBeijing ZKSK Technology Co.,LtdECK18-30-05-2302026-05-15
00191506039226Autotome™ Pro RX 44BOSTON SCIENTIFIC CORPORATIONM005843802023-10-25
00191506039233Autotome™ Pro RX 39BOSTON SCIENTIFIC CORPORATIONM005843902023-10-25
00191506039240Dreamtome™ Pro RX 44BOSTON SCIENTIFIC CORPORATIONM005844002023-10-25
00191506039257Dreamtome™ Pro RX 44BOSTON SCIENTIFIC CORPORATIONM005844102023-10-25
00191506039264Hydratome™ Pro RX 44BOSTON SCIENTIFIC CORPORATIONM005844202023-10-25
00191506039271Hydratome™ Pro RX 44BOSTON SCIENTIFIC CORPORATIONM005844302023-10-25
00191506039288Jagtome™ Pro RX 44BOSTON SCIENTIFIC CORPORATIONM005844402023-10-25
00191506039295Jagtome™ Pro RX 44BOSTON SCIENTIFIC CORPORATIONM005844502023-10-25