CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)

CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE) is an FDA 510(k)-cleared medical device (K973225) manufactured by Getinge/Castle, 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 February 9, 1998. Regulation: 8.