Vis-U-All Low Temperature Sterilization Pouches

Vis-U-All Low Temperature Sterilization Pouches is an FDA 510(k)-cleared medical device (K231500) 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 August 6, 2023. Regulation: 8.