About This 510(k) Submission
K240464 is an FDA 510(k) clearance for the WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Boston Scientific (Malborough, US). The FDA issued a Cleared decision on August 30, 2024, 196 days after receiving the submission on February 16, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.