STERRAD 100NX Sterilization System with ALLClear Technology (10104)

STERRAD 100NX Sterilization System with ALLClear Technology (10104) is an FDA 510(k)-cleared medical device (K252843) manufactured by Advanced Sterilization Products, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 14, 2026. Regulation: 8.