510(k) K172748

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack by Steris Corporations — Product Code FRC

K172748 is an FDA 510(k) premarket notification submitted by Steris Corporations for the device "VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack". The FDA issued a decision of Substantially Equivalent on February 9, 2018. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steris Corporations has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2018
Date Received
September 12, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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