510(k) K213545

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 by Steelco S.P.A. — Product Code FLE

K213545 is an FDA 510(k) premarket notification submitted by Steelco S.P.A. for the device "Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869". The FDA issued a decision of Substantially Equivalent on February 2, 2023. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880.