K202721 is an FDA 510(k) clearance for the Celerity 20 Steam Biological Indicator for IUSS. This device is classified as 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 January 8, 2021, 113 days after receiving the submission on September 17, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K202721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2020 |
| Decision Date | January 08, 2021 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |