INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT

INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT is an FDA 510(k)-cleared medical device (K093783) 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 August 22, 2010. Regulation: 8.