SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)

SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8) is an FDA 510(k)-cleared medical device (K904793) manufactured by Surgitek. 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 March 4, 1991. Regulation: 8.