IRRIGATION CHANNEL TUBING, MODEL 100135

IRRIGATION CHANNEL TUBING, MODEL 100135 is an FDA 510(k)-cleared medical device (K033695) 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 December 22, 2003. Regulation: 8.