MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER

MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER is an FDA 510(k)-cleared medical device (K052440) manufactured by Mentor Corporation. 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 October 10, 2005. Regulation: 8.