K140589 is an FDA 510(k) clearance for the STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by Mesa Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on December 3, 2014, 271 days after receiving the submission on March 7, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K140589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2014 |
| Decision Date | December 03, 2014 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRC - Indicator, Biological Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |