510(k) K941973

GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES by Medi-Globe Corp. — Product Code FGE

K941973 is an FDA 510(k) premarket notification submitted by Medi-Globe Corp. for the device "GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES". The FDA issued a decision of Substantially Equivalent on June 30, 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.