ACE STAPLER AND CARTRIDGE

ACE STAPLER AND CARTRIDGE is an FDA 510(k)-cleared medical device (K110829) manufactured by Barosense, 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 June 2, 2011. Regulation: 8.