510(k) K961262

WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS by Boston Scientific Scimed, Inc. — Product Code FGE

K961262 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS". The FDA issued a decision of Substantially Equivalent on May 10, 1996. 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 34 other 510(k) clearances on record.