510(k) K953827

GIP/MEDI-GLOBE ERCP CATHETERS by Medi-Globe Corp. — Product Code FGE

K953827 is an FDA 510(k) premarket notification submitted by Medi-Globe Corp. for the device "GIP/MEDI-GLOBE ERCP CATHETERS". The FDA issued a decision of Substantially Equivalent on September 1, 1995. 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.