INNOPORT LAPAROSCOPIC ACCESS DEVICE

INNOPORT LAPAROSCOPIC ACCESS DEVICE is an FDA 510(k)-cleared medical device (K090677) manufactured by Innovia, LLC. 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 May 6, 2009. Regulation: 8.