EXALT Model B Single-Use Bronchoscope

EXALT Model B Single-Use Bronchoscope is an FDA 510(k)-cleared medical device (K222014) manufactured by Boston Scientific Corporation. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 27, 2022. Regulation: 8.