Gabriel 3 Way EnFit Valve

Gabriel 3 Way EnFit Valve is an FDA 510(k)-cleared medical device (K201741) manufactured by Syncro Medical Innovations, Inc.. 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 November 4, 2020. Regulation: 8.