510(k) K163018

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

K163018 is an FDA 510(k) premarket notification submitted by Cook Ireland, Ltd. for the device "Zilver 635 Biliary Stent". The FDA issued a decision of SESU on December 23, 2016. 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.