R-PORT LAPAROSCOPIC ACCESS DEVICE

R-PORT LAPAROSCOPIC ACCESS DEVICE is an FDA 510(k)-cleared medical device (K070158) manufactured by Advanced Surgical Concepts. 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, 2007. Regulation: 8.