COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH

COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH is an FDA 510(k)-cleared medical device (K072521) manufactured by Cook Urological, 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 November 19, 2007. Regulation: 8.