EndoflipTM 300

EndoflipTM 300 is an FDA 510(k)-cleared medical device (K223705) manufactured by Covidien, 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 April 13, 2023. Regulation: 8.