StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) is an FDA 510(k)-cleared medical device (K200723) manufactured by Medtronic Navigation, 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 25, 2020. Regulation: 8.