About This 510(k) Submission
K171548 is an FDA 510(k) clearance for the Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on October 13, 2017, 140 days after receiving the submission on May 26, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.