AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)

AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) is an FDA 510(k)-cleared medical device (K250752) manufactured by Integra LifeSciences Corporation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 8, 2025. Regulation: 8.