INNERVUE DIAGNOSTIC SCOPE SYSTEM

INNERVUE DIAGNOSTIC SCOPE SYSTEM is an FDA 510(k)-cleared medical device (K040604) manufactured by Arthrotek, 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 June 3, 2004. Regulation: 8.