510(k) K240032

Celerity Chemical Indicator for enspire 3000 CLCSPS by STERIS Corporation — Product Code JOJ

K240032 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "Celerity Chemical Indicator for enspire 3000 CLCSPS". The FDA issued a decision of Substantially Equivalent on April 17, 2024. 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 17, 2024
Date Received
January 4, 2024
Clearance Type
Traditional
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