DiLumen Endolumenal Interventional Platform (DiLumen)

DiLumen Endolumenal Interventional Platform (DiLumen) is an FDA 510(k)-cleared medical device (K210851) 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 April 20, 2021. Regulation: 8.