510(k) K212424

AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers by STERIS Corporation — Product Code FLE

K212424 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers". The FDA issued a decision of Substantially Equivalent on Oct 28, 2021. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. STERIS Corporation has 204 other 510(k) clearances on record.