Digital ClarusScope System; Digital NeuroPEN System

Digital ClarusScope System; Digital NeuroPEN System is an FDA 510(k)-cleared medical device (K240535) manufactured by Clarus Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 24, 2024. Regulation: 8.