DA VINVI SURGICAL SYSTEM

DA VINVI SURGICAL SYSTEM is an FDA 510(k)-cleared medical device (K123329) 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 September 16, 2014. Regulation: 8.