510(k) K240464

WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV by Boston Scientific — Product Code FGE

K240464 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV". The FDA issued a decision of SESU on August 30, 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.