SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE
FDA 510(k) clearance K053128 · decided 2005-11-30
Clearance details
- K-number
- K053128
- Device name
- SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2005-11-08
- Decision date
- 2005-11-30
- Days to decision
- 22 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
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged recall (Z-1319-2012) | Boston Scientific Corporation | 2012-03-28 |