510(k) K222627

EndoGI S-Path Biliary Stent System by Endo GI Medical — Product Code FGE

K222627 is an FDA 510(k) premarket notification submitted by Endo GI Medical for the device "EndoGI S-Path Biliary Stent System". The FDA issued a decision of Substantially Equivalent on Sep 28, 2022. 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. Endo GI Medical has 1 other 510(k) clearance on record.