EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable
FDA 510(k) clearance K142999 · decided 2014-11-19
Clearance details
- K-number
- K142999
- Device name
- EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable
- Applicant
- ArthroCare Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-10-17
- Decision date
- 2014-11-19
- Days to decision
- 33 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
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage recall (Z-2105-2015) | ArthroCare Corporation | 2015-07-18 |
| EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are recall (Z-1832-2015) | ArthroCare Medical Corporation | 2015-06-25 |
| PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices a recall (Z-1833-2015) | ArthroCare Medical Corporation | 2015-06-25 |