ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT CABLE; FOOT CONTROL; POWER CORD; WANDS
FDA 510(k) clearance K030551 · decided 2003-03-07
Clearance details
- K-number
- K030551
- Device name
- ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT CABLE; FOOT CONTROL; POWER CORD; WANDS
- Applicant
- Arthrocare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-21
- Decision date
- 2003-03-07
- Days to decision
- 14 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 |
|---|---|---|
| ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01, Manufactured by recall (Z-1900-2009) | ArthroCare Corporation | 2009-08-30 |