510(k) K232485

AMSCO 600 Steam Sterilizer by Steris — Product Code FLE

K232485 is an FDA 510(k) premarket notification submitted by Steris for the device "AMSCO 600 Steam Sterilizer". The FDA issued a decision of Substantially Equivalent on September 13, 2023. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Steris has at least 10 other 510(k) clearances on record.