Outlook Surgical Versa One System (8900139)

Outlook Surgical Versa One System (8900139) is an FDA 510(k)-cleared medical device (K241731) manufactured by Resnent, LLC. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 10, 2025. Regulation: 8.