510(k) K012216

NIROYAL BILIARY PREMOUNTED STENT SYSTEM by Boston Scientific Scimed, Inc. — Product Code FGE

K012216 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "NIROYAL BILIARY PREMOUNTED STENT SYSTEM". The FDA issued a decision of SESU on August 17, 2001. 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 Scimed, Inc. has at least 10 other 510(k) clearances on record.