Acclarent NavWire Sinus Navigation Guidewire

Acclarent NavWire Sinus Navigation Guidewire is an FDA 510(k)-cleared medical device (K161697) manufactured by Acclarent, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 23, 2016. Regulation: 8.