NAVIGUS PEEL AWAY INTRODUCER

NAVIGUS PEEL AWAY INTRODUCER is an FDA 510(k)-cleared medical device (K002330) 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 October 17, 2000. Regulation: 8.