SURGIQUEST AIRSEAL IFS

SURGIQUEST AIRSEAL IFS is an FDA 510(k)-cleared medical device (K132169) manufactured by Surgiquest, Inc.. 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 August 21, 2013. Regulation: 8.