APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE

APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE is an FDA 510(k)-cleared medical device (K014047) manufactured by Applied Medical Resources 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 February 27, 2002. Regulation: 8.