ENDOGATOR ADVANTAGE IRRIGATION PUMP

ENDOGATOR ADVANTAGE IRRIGATION PUMP is an FDA 510(k)-cleared medical device (K113119) 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 April 26, 2012. Regulation: 8.