PENTAX Medical EPK-3000 Video Imaging System

PENTAX Medical EPK-3000 Video Imaging System is an FDA 510(k)-cleared medical device (K172156) manufactured by Pentax Medical. 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 4, 2018. Regulation: 8.