K111375 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 September 14, 2012, 487 days after receiving the submission on May 16, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K111375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2011 |
| Decision Date | September 14, 2012 |
| Days to Decision | 487 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 |