About This 510(k) Submission
K101530 is an FDA 510(k) clearance for the EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D, 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 March 29, 2011, 299 days after receiving the submission on June 3, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.