NEOGUIDE ENDOSCOPY SYSTEM

NEOGUIDE ENDOSCOPY SYSTEM is an FDA 510(k)-cleared medical device (K070622) 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 August 13, 2007. Regulation: 8.