
Lumendi, LLC
Free shipping on orders over $99 · 30-day returns
DiLumen C1, EZ1 and Tool Mount is an FDA 510(k)-cleared medical device (K221452) 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 February 9, 2023. Regulation: 8.