STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR

STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR is an FDA 510(k)-cleared medical device (K122044) manufactured by Advanced Sterilization Products. 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 October 3, 2012. Regulation: 8.