INTUITIVE SURGICAL ULTRASONIC SHEARS

INTUITIVE SURGICAL ULTRASONIC SHEARS is an FDA 510(k)-cleared medical device (K011281) 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 July 23, 2001. Regulation: 8.