STERRAD CYCLESURE BIOLOGICAL INDICATOR
FDA 510(k) clearance K103222 · decided 2011-02-25
Clearance details
- K-number
- K103222
- Device name
- STERRAD CYCLESURE BIOLOGICAL INDICATOR
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2010-11-01
- Decision date
- 2011-02-25
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- FRC
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a stand recall (Z-0604-2014) | Advanced Sterilization Products | 2013-12-28 |
| STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with St recall (Z-0520-2013) | Advanced Sterilization Products | 2012-12-12 |
| STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part recall (Z-2100-2012) | Advanced Sterilization Products | 2012-07-27 |
| Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological recall (Z-1773-2012) | Advanced Sterilization Products | 2012-06-06 |