510(k) K171989

Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter by Wilson-Cook Medical, Inc. — Product Code ODD

K171989 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter". The FDA issued a decision of Substantially Equivalent on March 20, 2018. The device falls under product code ODD (Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula), a Class II device regulated under 21 CFR 876.1500. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.