RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER

RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER is an FDA 510(k)-cleared medical device (K962472) manufactured by Rusch Intl.. 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 August 26, 1996. Regulation: 8.