510(k) K222440

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays by Steris — Product Code FRG

K222440 is an FDA 510(k) premarket notification submitted by Steris for the device "Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays". The FDA issued a decision of Substantially Equivalent on September 9, 2022. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Steris has at least 10 other 510(k) clearances on record.