PRIMUS Healthcare Sterilizer (Model PSS11-HC)

PRIMUS Healthcare Sterilizer (Model PSS11-HC) is an FDA 510(k)-cleared medical device (K221474) manufactured by Primus Sterilizer Company, LLC. 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, 2023. Regulation: 8.