510(k) K242845

EGIS Biliary Double Bare Stent (BDB080405) by S&G Biotech, Inc. — Product Code FGE

K242845 is an FDA 510(k) premarket notification submitted by S&G Biotech, Inc. for the device "EGIS Biliary Double Bare Stent (BDB080405)". The FDA issued a decision of SESU on June 25, 2025. 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. S&G Biotech, Inc. has at least 1 other 510(k) clearance on record.