510(k) K162104

C-Flex Ureteral Stent Set by Cook Incorporated — Product Code FAD

K162104 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "C-Flex Ureteral Stent Set". The FDA issued a decision of Substantially Equivalent - Kit on Apr 24, 2017. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Cook Incorporated has 174 other 510(k) clearances on record.