ENDOWRIST ONE VESSEL SEALER

ENDOWRIST ONE VESSEL SEALER is an FDA 510(k)-cleared medical device (K130266) 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 28, 2013. Regulation: 8.