Nutrisafe 2- ENFit Adaptor

Nutrisafe 2- ENFit Adaptor is an FDA 510(k)-cleared medical device (K151237) manufactured by Vygon. 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 February 8, 2016. Regulation: 8.