FDA product code GXD: Generator, Lesion, Radiofrequency
GXD is the FDA product code for generator, lesion, radiofrequency. It is a Class II device, regulated under 21 CFR 882.4400 and reviewed by the Neurology panel. FDA has cleared 37 510(k) submissions under GXD, 6 in the last five years, from 27 different applicants. The average 510(k) review took 200 days (median 141); 128 days on average over the last three years. FDA has posted 7 recalls for GXD devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Generator, Lesion, Radiofrequency |
| Device class | Class II |
| Regulation | 21 CFR 882.4400 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GXD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 120 |
| 2019 | 1 | 174 |
| 2020 | 2 | 146 |
| 2022 | 1 | 438 |
| 2023 | 2 | 301 |
| 2024 | 2 | 149 |
| 2025 | 1 | 106 |
Compare with all 510(k) review times · Search every GXD clearance
Top GXD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Radionics, Inc. | 4 | 1998-10-05 |
| Diros Technology, Inc. | 3 | 2010-01-22 |
| Avanos Medical, Inc. | 2 | 2024-08-14 |
| ABBOTT MEDICAL | 2 | 2022-01-21 |
| Neuro Therm, Inc. | 2 | 2011-09-20 |
22 more applicants have GXD clearances. See the full list in Caduvo.
Most recent GXD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251247 | Boston Scientific Neuromodulation Corporation | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) | 2025-08-07 | 106 |
| K242057 | Avanos Medical, Inc. | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | 2024-08-14 | 30 |
| K232632 | Epimed International | Racz Neurostat RF Generator | 2024-05-24 | 268 |
| K231675 | Neuroone Medical Technologies Corp. | OneRF Ablation System | 2023-12-06 | 181 |
| K220122 | Rf Innovations, Inc. | APEX 6 | 2023-03-15 | 421 |
Recalls for GXD devices
7 product recalls in 7 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2023-09-28.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code GXD?
GXD is the FDA product code for generator, lesion, radiofrequency. It is a Class II device, regulated under 21 CFR 882.4400 and reviewed by the Neurology panel.
What device class is GXD?
Class II, regulation 21 CFR 882.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code GXD?
Across 37 cleared submissions the average was 200 days from receipt to decision (median 141).
Which companies have the most GXD clearances?
Radionics, Inc. (4); Diros Technology, Inc. (3); Avanos Medical, Inc. (2); ABBOTT MEDICAL (2); Neuro Therm, Inc. (2).
Have GXD devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2023-09-28.
Next steps
- Run an FDA pathway report with predicate devices for product code GXD
- Run a recall and safety report across every GXD manufacturer
- Watch product code GXD 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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