Submission Details
| 510(k) Number | K231490 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 23, 2023 |
| Decision Date | August 07, 2023 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator
Aug 2023
Decision
76d
Days
Class 2
Risk
About This 510(k) Submission
K231490 is an FDA 510(k) clearance for the Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator, a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on August 7, 2023, 76 days after receiving the submission on May 23, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.
Device Classification
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2800 |
Manufacturer
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