STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR
FDA 510(k) clearance K122044 · decided 2012-10-04
Clearance details
- K-number
- K122044
- Device name
- STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR
- Applicant
- Advanced Sterilization Products
- Decision
- Substantially Equivalent
- Date received
- 2012-07-12
- Decision date
- 2012-10-04
- Days to decision
- 84 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
No recalls on record reference this clearance.