COAXIAL BALLOON URETHRAL DILATOR

COAXIAL BALLOON URETHRAL DILATOR is an FDA 510(k)-cleared medical device (K831384) manufactured by Thomas J. Fogarty, M.D.. 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 July 25, 1983. Regulation: 8.