ClearPoint Array System (version 1.1)

ClearPoint Array System (version 1.1) is an FDA 510(k)-cleared medical device (K214040) manufactured by ClearPoint Neuro, 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 April 11, 2022. Regulation: 8.