NAVIGATOR ENDOSCOPY SYSTEM

NAVIGATOR ENDOSCOPY SYSTEM is an FDA 510(k)-cleared medical device (K052930) manufactured by Neoguide Systems, 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 January 30, 2006. Regulation: 8.