STELTHSTATION WIRELESS SURGEON MOUSE

STELTHSTATION WIRELESS SURGEON MOUSE is an FDA 510(k)-cleared medical device (K051029) manufactured by Medtronic Surgical Navigation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2005. Regulation: 8.