GENICON SUCTION IRRIGATION SYSTEM

GENICON SUCTION IRRIGATION SYSTEM is an FDA 510(k)-cleared medical device (K041967) manufactured by Genicon. 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 November 11, 2004. Regulation: 8.