510(k) K261055

AMSCO 700 Steam Sterilizer by STERIS Corporation — Product Code FLE

K261055 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "AMSCO 700 Steam Sterilizer". The FDA issued a decision of Substantially Equivalent on June 24, 2026. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. STERIS Corporation has at least 10 other 510(k) clearances on record.