THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM

THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM is an FDA 510(k)-cleared medical device (K091783) manufactured by Avantis Medical 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 July 6, 2009. Regulation: 8.