Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack

Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack is an FDA 510(k)-cleared medical device (K223717) manufactured by STERIS Corporation. 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 June 14, 2023. Regulation: 8.