Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port

Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port is an FDA 510(k)-cleared medical device (K180622) manufactured by Covidien. 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 October 22, 2018. Regulation: 8.