510(k) K171548

Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter by Wilson-Cook Medical, Inc. — Product Code FGE

K171548 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter". The FDA issued a decision of Substantially Equivalent on Oct 13, 2017. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Wilson-Cook Medical, Inc. has 125 other 510(k) clearances on record.