SELF ADHERING NAVIGUS GUIDE

SELF ADHERING NAVIGUS GUIDE is an FDA 510(k)-cleared medical device (K001192) manufactured by Image-Guided Neurologics, 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 June 6, 2000. Regulation: 8.