WOUND PROTECTOR

WOUND PROTECTOR is an FDA 510(k)-cleared medical device (K120061) manufactured by Covidien, Formerly US Surgical A Divison of Tyco H. 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 March 26, 2012. Regulation: 8.