MENTOR SELF-CATH PLUS

MENTOR SELF-CATH PLUS is an FDA 510(k)-cleared medical device (K003784) manufactured by Mentor 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 March 4, 2001. Regulation: 8.