510(k) K262913

Protégé™ EverFlex™ Self-expanding Peripheral Stent System by Medtronic, Inc. — Product Code FGE

K262913 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Protégé™ EverFlex™ Self-expanding Peripheral Stent System". The FDA issued a decision of Substantially Equivalent on September 17, 2026. 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. Medtronic, Inc. has at least 10 other 510(k) clearances on record.