THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
FDA 510(k) clearance K113872 · decided 2012-03-08
Clearance details
- K-number
- K113872
- Device name
- THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
- Applicant
- Vidacare Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-12-30
- Decision date
- 2012-03-08
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Prod recall (Z-1374-2021) | Arrow International Inc | 2021-04-07 |