A-LAP SET (A-LAP, EZAXESS, TROCAR)

A-LAP SET (A-LAP, EZAXESS, TROCAR) is an FDA 510(k)-cleared medical device (K082291) manufactured by Ezsurgical. 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 January 1, 2009. Regulation: 8.