510(k) K163468

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered by Cook Ireland, Ltd. — Product Code MUM

K163468 is an FDA 510(k) premarket notification submitted by Cook Ireland, Ltd. for the device "Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered". The FDA issued a decision of Substantially Equivalent on May 4, 2017. The device falls under product code MUM (Stent, Metallic, Expandable, Duodenal), a Class II device regulated under 21 CFR 878.3610. Cook Ireland, Ltd. has at least 10 other 510(k) clearances on record.