510(k) K031360

GI SUPPLY BILIARY STENT by Gi Supply — Product Code FGE

K031360 is an FDA 510(k) premarket notification submitted by Gi Supply for the device "GI SUPPLY BILIARY STENT". The FDA issued a decision of Substantially Equivalent on September 24, 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. Gi Supply has at least 9 other 510(k) clearances on record.