SECURE W/30MM DIAM, SHEATH & ADHESIVE

SECURE W/30MM DIAM, SHEATH & ADHESIVE is an FDA 510(k)-cleared medical device (K840703) manufactured by Warne Surgical Products, 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 March 21, 1984. Regulation: 8.