GuardianTM Burr Hole Cover System

GuardianTM Burr Hole Cover System is an FDA 510(k)-cleared medical device (K181382) manufactured by St Jude Medical. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 19, 2018. Regulation: 8.