VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
FDA 510(k) K172748 · Steris Corporations
510(k) numberK172748
Submission
- Device name
- VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
- Applicant
- Steris Corporations
Mentor, OH, US - Received
- September 12, 2017
- Decision date
- February 9, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
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| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 3M Company | 11/25/2024SE |
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| K183295 | Celerity HP Chemical Indicator (CI)JOJ · Abbreviated | 01/04/2019SE |
| K183300 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator…FRC · Traditional | 01/03/2019SE |
| K182931 | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack…FRC · Special | 11/20/2018SE |
| K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing SystemMED · Special | 04/04/2018SE |
Questions and answers
When was VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack cleared by the FDA?
VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack (K172748) received a 510(k) decision of Substantially Equivalent on February 9, 2018, 150 days after the submission was received.
What is the product code of K172748?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.