GXI
- Product code
- GXI
- Device name
- Probe, Radiofrequency Lesion
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4725
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 6
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 66 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253907 | 2026-04-16 | ABBOTT MEDICAL | Disposable Radiofrequency Cannula | |
| K251802 | 2026-02-13 | Merit Medical Systems, Inc. | STAR RF Ablation System | |
| K251243 | 2025-08-15 | Neuroone Medical Technologies Corp. | OneRF Trigeminal Nerve Radiofrequency Probes | |
| K242841 | 2025-05-27 | ABBOTT MEDICAL | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE… | FDA |
| K250213 | 2025-05-15 | Stryker Instruments | OptaBlate BVN Intraosseous Nerve Ablation System (10… | |
| K241367 | 2025-01-23 | Shanghai Samedical & Plastic Instrumen… | RF Cannula | FDA |
Official FDA classification page: GXI
Classification and pathway per current FDA publications. Data from openFDA (CC0).