STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)

STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) is an FDA 510(k)-cleared medical device (K250802) 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 13, 2025. Regulation: 8.