ENDO GATOR SYSTEM

ENDO GATOR SYSTEM is an FDA 510(k)-cleared medical device (K031773) manufactured by Byrne Medical, 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 June 23, 2003. Regulation: 8.