510(k) K163169

Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent by Cook Ireland, Ltd. — Product Code FGE

K163169 is an FDA 510(k) premarket notification submitted by Cook Ireland, Ltd. for the device "Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent". The FDA issued a decision of SESU on February 7, 2017. 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. Cook Ireland, Ltd. has at least 10 other 510(k) clearances on record.