RUSCH URODYNAMIC RECTAL BALLOON CATHETER

RUSCH URODYNAMIC RECTAL BALLOON CATHETER is an FDA 510(k)-cleared medical device (K952573) 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 June 14, 1995. Regulation: 8.