URO-MALE INCONTINENCE CATHETER

URO-MALE INCONTINENCE CATHETER is an FDA 510(k)-cleared medical device (K841224) manufactured by Gil-Med Industries C/O Kegan & Kegan, Ltd.. 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 May 1, 1984. Regulation: 8.