LUMEN-4 URODYNAMIC CATHETER

LUMEN-4 URODYNAMIC CATHETER is an FDA 510(k)-cleared medical device (K833628) manufactured by Surgitek. 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 27, 1983. Regulation: 8.