510(k) K012822

MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX by Boston Scientific Scimed, Inc. — Product Code FGE

K012822 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX". The FDA issued a decision of SESU on October 24, 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.