510(k) K183401

Vis-U-All Low Temperature Sterilization Pouch/Tubing by STERIS Corporation — Product Code FRG

K183401 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "Vis-U-All Low Temperature Sterilization Pouch/Tubing". The FDA issued a decision of Substantially Equivalent on Mar 1, 2019. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. STERIS Corporation has 204 other 510(k) clearances on record.