TROCAR/CANNULA/SHEATH SET

TROCAR/CANNULA/SHEATH SET is an FDA 510(k)-cleared medical device (K853337) manufactured by American Edwards Laboratories. 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 22, 1985. Regulation: 8.