K122044 is an FDA 510(k) clearance for the STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR. This device is classified as a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC).
Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on October 4, 2012, 84 days after receiving the submission on July 12, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K122044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2012 |
| Decision Date | October 04, 2012 |
| Days to Decision | 84 days |
| Submission Type | Special |
| 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 |