Phantom XL Insulated Dilators

Phantom XL Insulated Dilators is an FDA 510(k)-cleared medical device (K231691) manufactured by TeDan Surgical Innovations, 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 June 28, 2023. Regulation: 8.