510(k) K254179

Drainage Catheter by Canyon Medical, Inc. — Product Code FGE

K254179 is an FDA 510(k) premarket notification submitted by Canyon Medical, Inc. for the device "Drainage Catheter". The FDA issued a decision of Substantially Equivalent on September 18, 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. Canyon Medical, Inc. has at least 5 other 510(k) clearances on record.