LEVEEN NEEDLE ELECTRODE
FDA 510(k) clearance K000032 · decided 2000-03-30
Clearance details
- K-number
- K000032
- Device name
- LEVEEN NEEDLE ELECTRODE
- Applicant
- Radiotherapeutics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-01-05
- Decision date
- 2000-03-30
- Days to decision
- 85 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), ( recall (Z-0079-2013) | Boston Scientific Corporation | 2012-10-18 |
| Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For ti recall (Z-1876-2009) | Boston Scientific Corp | 2009-09-09 |
| Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For ti recall (Z-1877-2009) | Boston Scientific Corp | 2009-09-09 |