510(k) K230558

Revital-Ox PAA High Level Disinfectant Chemical Indicator by STERIS Corporation — Product Code JOJ

K230558 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "Revital-Ox PAA High Level Disinfectant Chemical Indicator". The FDA issued a decision of Substantially Equivalent on July 17, 2023. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. STERIS Corporation has at least 10 other 510(k) clearances on record.