MODIFICATION TO ARTHROCARE ARTHROWANDS
FDA 510(k) clearance K083306 · decided 2008-12-10
Clearance details
- K-number
- K083306
- Device name
- MODIFICATION TO ARTHROCARE ARTHROWANDS
- Applicant
- Arthrocare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-10
- Decision date
- 2008-12-10
- Days to decision
- 30 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model recall (Z-0579-2015) | ArthroCare Medical Corporation | 2014-12-16 |