510(k) K223354

EGIS Biliary Single Bare Stent by S&G Biotech, Inc. — Product Code FGE

K223354 is an FDA 510(k) premarket notification submitted by S&G Biotech, Inc. for the device "EGIS Biliary Single Bare Stent". The FDA issued a decision of SESU on September 21, 2023. 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.