ClearPoint System (Software Version 2.2)

ClearPoint System (Software Version 2.2) is an FDA 510(k)-cleared medical device (K233243) 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 November 26, 2023. Regulation: 8.