510(k) K173626

Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles by STERIS Corporation — Product Code FRC

K173626 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles". The FDA issued a decision of Substantially Equivalent on Feb 21, 2018. 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.