ASSURE-MALE EXTERNAL INCONTINCE CATHETER

ASSURE-MALE EXTERNAL INCONTINCE CATHETER is an FDA 510(k)-cleared medical device (K821848) manufactured by Medical Design & Manufacturing 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 August 9, 1982. Regulation: 8.