ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE

ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE is an FDA 510(k)-cleared medical device (K082569) manufactured by Entellus Medical, Inc.. 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 September 17, 2008. Regulation: 8.