510(k) K242950

WallFlex Biliary PLUS RX Stent System by Boston Scientific — Product Code FGE

K242950 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "WallFlex Biliary PLUS RX Stent System". The FDA issued a decision of SESU on December 6, 2024. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Boston Scientific has at least 10 other 510(k) clearances on record.