510(k) K010714

EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 by Medi-Globe Corp. — Product Code FGE

K010714 is an FDA 510(k) premarket notification submitted by Medi-Globe Corp. for the device "EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830". The FDA issued a decision of Substantially Equivalent on January 21, 2003. 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.