Surgisleeve Wound Protector

Surgisleeve Wound Protector is an FDA 510(k)-cleared medical device (K143091) manufactured by Covidien, LLC. 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 November 25, 2014. Regulation: 8.