
Cook Incorporated
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Universa Firm Ureteral Stents and Stent Sets is an FDA 510(k)-cleared medical device (K161236) manufactured by Cook Incorporated. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 26, 2017. Regulation: 8.