510(k) K010549

BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) by Medi-Globe Corp. — Product Code FGE

K010549 is an FDA 510(k) premarket notification submitted by Medi-Globe Corp. for the device "BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)". The FDA issued a decision of Substantially Equivalent (kit) on January 18, 2002. 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. Medi-Globe Corp. has at least 10 other 510(k) clearances on record.