ENTRACARE GASTROSTOMY FEEDING TUBE

ENTRACARE GASTROSTOMY FEEDING TUBE is an FDA 510(k)-cleared medical device (K092418) manufactured by Entracare, 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 October 22, 2009. Regulation: 8.