ARTHROCARE CAVITY SPINEWAND
FDA 510(k) clearance K063172 · decided 2007-04-27
Clearance details
- K-number
- K063172
- Device name
- ARTHROCARE CAVITY SPINEWAND
- Applicant
- Arthrocare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-18
- Decision date
- 2007-04-27
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissu recall (Z-0623-2016) | ArthroCare Corporation | 2016-01-08 |