URODYNAMIC CATHETERS

URODYNAMIC CATHETERS is an FDA 510(k)-cleared medical device (K923464) manufactured by R.L. Medical Corp.. 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 February 4, 1993. Regulation: 8.