510(k) K242189

CELERITY HP Indicator Tape (PCC077) by Steris — Product Code JOJ

K242189 is an FDA 510(k) premarket notification submitted by Steris for the device "CELERITY HP Indicator Tape (PCC077)". The FDA issued a decision of Substantially Equivalent on August 20, 2024. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steris has at least 10 other 510(k) clearances on record.