UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER

UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER is an FDA 510(k)-cleared medical device (K851684) manufactured by Urotec Systems 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 July 1, 1985. Regulation: 8.