510(k) K213412

VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM by Steris Corparation — Product Code JOJ

K213412 is an FDA 510(k) premarket notification submitted by Steris Corparation for the device "VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM". The FDA issued a decision of Substantially Equivalent on January 21, 2022. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steris Corparation has at least 1 other 510(k) clearance on record.