510(k) K101530

EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D by Cook Ireland, Ltd. — Product Code MUM

K101530 is an FDA 510(k) premarket notification submitted by Cook Ireland, Ltd. for the device "EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D". The FDA issued a decision of Substantially Equivalent on March 29, 2011. 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.