Entellus Medical Reinforced Anesthesia Needle

Entellus Medical Reinforced Anesthesia Needle is an FDA 510(k)-cleared medical device (K163435) manufactured by Entellus Medical, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 4, 2017. Regulation: 8.