Genesis Reusable Rigid Container System
FDA 510(k) clearance K142529 · decided 2015-01-08
Clearance details
- K-number
- K142529
- Device name
- Genesis Reusable Rigid Container System
- Applicant
- Carefusion 2200, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-09-09
- Decision date
- 2015-01-08
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- KCT
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Vernon Hills, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and pr recall (Z-1236-2023) | Carefusion 2200 Inc | 2023-03-09 |
| CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP recall (Z-0203-2023) | Carefusion 2200 Inc | 2022-11-11 |