ENDOWRIST STAPLER SYSTEM

ENDOWRIST STAPLER SYSTEM is an FDA 510(k)-cleared medical device (K113706) manufactured by Intuitive Surgical, 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 October 16, 2012. Regulation: 8.