ENFit to ENFit Extension Sets

ENFit to ENFit Extension Sets is an FDA 510(k)-cleared medical device (K230326) manufactured by Vesco Medical. 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 1, 2023. Regulation: 8.