510(k) K231500

Vis-U-All Low Temperature Sterilization Pouches by STERIS Corporation — Product Code FRG

K231500 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "Vis-U-All Low Temperature Sterilization Pouches". The FDA issued a decision of Substantially Equivalent on August 7, 2023. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. STERIS Corporation has at least 10 other 510(k) clearances on record.