CORTEK CYSTOSCOPE

CORTEK CYSTOSCOPE is an FDA 510(k)-cleared medical device (K000197) manufactured by Cortek Endoscopy, 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 March 2, 2000. Regulation: 8.