ARTHROCARE ARTHROWANDS
FDA 510(k) clearance K033584 · decided 2003-11-28
Clearance details
- K-number
- K033584
- Device name
- ARTHROCARE ARTHROWANDS
- Applicant
- Arthrocare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-13
- Decision date
- 2003-11-28
- Days to decision
- 15 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
+ Add to Predicate Builder ◉ Watch Arthrocare Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The pr recall (Z-2309-2008) | ArthroCare Corporation | 2008-09-19 |