510(k) K161236

Universa Firm Ureteral Stents and Stent Sets by Cook Incorporated — Product Code FAD

K161236 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Universa Firm Ureteral Stents and Stent Sets". The FDA issued a decision of Substantially Equivalent on Jan 27, 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.