KARL STORZ NAV1 Electromagnetic Navigation System

KARL STORZ NAV1 Electromagnetic Navigation System is an FDA 510(k)-cleared medical device (K161555) manufactured by Karl Storz Endoscopy America, 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 20, 2016. Regulation: 8.