About This 510(k) Submission
K200257 is an FDA 510(k) clearance for the WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System, a Stent, Colonic, Metallic, Expandable (Class II — Special Controls, product code MQR), submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on April 17, 2020, 74 days after receiving the submission on February 3, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.