Stealth-Midas MR8 System

Stealth-Midas MR8 System is an FDA 510(k)-cleared medical device (K183644) manufactured by Medtronic Powered Surgical Solutions. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 21, 2019. Regulation: 8.