SILS PORT

SILS PORT is an FDA 510(k)-cleared medical device (K103253) manufactured by Coviden (Formerly Registered AS US Surgical, A Div. 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 February 23, 2011. Regulation: 8.