About This 510(k) Submission
K163468 is an FDA 510(k) clearance for the Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered, a Stent, Metallic, Expandable, Duodenal (Class II — Special Controls, product code MUM), submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on May 4, 2017, 143 days after receiving the submission on December 12, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.