510(k) K211500

AMSCO 600 Medium Steam Sterilizer by STERIS Corporation — Product Code FLE

K211500 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "AMSCO 600 Medium Steam Sterilizer". The FDA issued a decision of Substantially Equivalent on Aug 25, 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.