FDA product code GXI: Probe, Radiofrequency Lesion
GXI is the FDA product code for probe, radiofrequency lesion. It is a Class II device, regulated under 21 CFR 882.4725 and reviewed by the Neurology panel. FDA has cleared 66 510(k) submissions under GXI, 8 in the last five years, from 32 different applicants. The average 510(k) review took 132 days (median 98); 186 days on average over the last three years. FDA has posted 29 recalls for GXI devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Probe, Radiofrequency Lesion |
| Device class | Class II |
| Regulation | 21 CFR 882.4725 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GXI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 126 |
| 2018 | 1 | 214 |
| 2019 | 3 | 68 |
| 2020 | 3 | 231 |
| 2022 | 2 | 90 |
| 2025 | 4 | 182 |
| 2026 | 2 | 189 |
Compare with all 510(k) review times · Search every GXI clearance
Top GXI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baylis Medical Co., Inc. | 7 | 2010-08-10 |
| Diros Technology, Inc. | 5 | 2017-06-27 |
| Relievant Medsystems | 4 | 2019-05-03 |
| Smith & Nephew, Inc. | 4 | 2009-07-16 |
| Cosman Medical, Inc. | 4 | 2008-10-14 |
27 more applicants have GXI clearances. See the full list in Caduvo.
Most recent GXI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253907 | ABBOTT MEDICAL | Disposable Radiofrequency Cannula | 2026-04-16 | 132 |
| K251802 | Merit Medical Systems, Inc. | STAR RF Ablation System | 2026-02-13 | 246 |
| K251243 | Neuroone Medical Technologies Corp. | OneRF Trigeminal Nerve Radiofrequency Probes | 2025-08-15 | 115 |
| K242841 | ABBOTT MEDICAL | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | 2025-05-27 | 250 |
| K250213 | Stryker Instruments | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) | 2025-05-15 | 111 |
Recalls for GXI devices
29 product recalls in 16 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-04-29.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 6 |
| 2020 | 7 |
| 2024 | 1 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code GXI?
GXI is the FDA product code for probe, radiofrequency lesion. It is a Class II device, regulated under 21 CFR 882.4725 and reviewed by the Neurology panel.
What device class is GXI?
Class II, regulation 21 CFR 882.4725. Typical premarket route: 510(k).
How long does a 510(k) take for product code GXI?
Across 66 cleared submissions the average was 132 days from receipt to decision (median 98).
Which companies have the most GXI clearances?
Baylis Medical Co., Inc. (7); Diros Technology, Inc. (5); Relievant Medsystems (4); Smith & Nephew, Inc. (4); Cosman Medical, Inc. (4).
Have GXI devices been recalled?
Yes: 29 product recalls across 16 recall events; the most recent began 2026-04-29.
Next steps
- Run an FDA pathway report with predicate devices for product code GXI
- Run a recall and safety report across every GXI manufacturer
- Watch product code GXI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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