510(k) K170070

VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles by STERIS Corporation — Product Code FRC

K170070 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles". The FDA issued a decision of Substantially Equivalent on Apr 28, 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.