510(k) K233187

Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) by Steris — Product Code JOJ

K233187 is an FDA 510(k) premarket notification submitted by Steris for the device "Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)". The FDA issued a decision of Substantially Equivalent on October 27, 2023. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2023
Date Received
September 28, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type