510(k) K092352

SCUBA BILIARY STENT SYSTEM by Invatec S.P.A. — Product Code FGE

K092352 is an FDA 510(k) premarket notification submitted by Invatec S.P.A. for the device "SCUBA BILIARY STENT SYSTEM". The FDA issued a decision of SESU on March 16, 2010. 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. Invatec S.P.A. has at least 3 other 510(k) clearances on record.