GXD
- Product code
- GXD
- Device name
- Generator, Lesion, Radiofrequency
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4400
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 37 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251247 | 2025-08-07 | Boston Scientific Neuromodulation Corp… | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 … | |
| K242057 | 2024-08-14 | Avanos Medical, Inc. | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BA… | — |
| K232632 | 2024-05-24 | Epimed International | Racz Neurostat RF Generator | |
| K231675 | 2023-12-06 | Neuroone Medical Technologies Corp. | OneRF Ablation System |
Official FDA classification page: GXD
Classification and pathway per current FDA publications. Data from openFDA (CC0).