DiLumen C2 and Tool Mount

DiLumen C2 and Tool Mount is an FDA 510(k)-cleared medical device (K211819) manufactured by Lumendi, 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 21, 2021. Regulation: 8.