Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga

Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga is an FDA 510(k)-cleared medical device (K163537) manufactured by Covidien, 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 April 20, 2017. Regulation: 8.