DiLumen Endolumenal Interventional Scissors (DiLumen Is)

DiLumen Endolumenal Interventional Scissors (DiLumen Is) is an FDA 510(k)-cleared medical device (K173405) manufactured by Lumendi, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 21, 2018. Regulation: 8.