STERRAD CYCLESURE BIOLOGICAL INDICATOR
FDA 510(k) clearance K031226 · decided 2003-05-02
Clearance details
- K-number
- K031226
- Device name
- STERRAD CYCLESURE BIOLOGICAL INDICATOR
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2003-04-18
- Decision date
- 2003-05-02
- Days to decision
- 14 days
- Clearance type
- Special
- 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, Product Code 14324. The Sterrad CycleSure Biologic recall (Z-0066-2010) | Advanced Sterilization Products | 2009-10-20 |