ENDOWRIST ONE SUCTION/IRRIGATOR

ENDOWRIST ONE SUCTION/IRRIGATOR is an FDA 510(k)-cleared medical device (K110451) 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 August 25, 2011. Regulation: 8.