GXZ
- Product code
- GXZ
- Device name
- Electrode, Needle
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1350
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 53 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241045 | 2024-12-11 | Technomed Europe | Disposable Subdermal Needle Electrode, Corkscrew | |
| K232581 | 2023-12-04 | Suzhou Haishen Medical Device Associat… | Medical Disposable Sterile Needle Electrode |
Official FDA classification page: GXZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).