510(k) K243876

VERIFY STEAM Integrating Indicator by STERIS Corporation — Product Code JOJ

K243876 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "VERIFY STEAM Integrating Indicator". The FDA issued a decision of Substantially Equivalent on April 25, 2025. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2025
Date Received
December 18, 2024
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