ViziShot 2 FLEX

ViziShot 2 FLEX is an FDA 510(k)-cleared medical device (K163469) manufactured by Olympus Surgical Technologies America. 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 April 5, 2017. Regulation: 8.