GASTRO-ENTEROSTOMY TUBE

GASTRO-ENTEROSTOMY TUBE is an FDA 510(k)-cleared medical device (K852707) manufactured by Medical Innovations 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 August 13, 1985. Regulation: 8.