ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;
FDA 510(k) clearance K080282 · decided 2008-02-15
Clearance details
- K-number
- K080282
- Device name
- ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;
- Applicant
- Arthrocare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-02-04
- Decision date
- 2008-02-15
- Days to decision
- 11 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 |
|---|---|---|
| TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; T recall (Z-1321-2016) | ArthroCare Corporation | 2016-04-05 |