510(k) K171504

VERIFY Assert VH2O2 Self-Contained Biological Indicator by STERIS Corporation — Product Code FRC

K171504 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "VERIFY Assert VH2O2 Self-Contained Biological Indicator". The FDA issued a decision of Substantially Equivalent on Aug 22, 2017. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. STERIS Corporation has 204 other 510(k) clearances on record.