FDA product code GWF: Stimulator, Electrical, Evoked Response
GWF is the FDA product code for stimulator, electrical, evoked response. It is a Class II device, regulated under 21 CFR 882.1870 and reviewed by the Neurology panel. FDA has cleared 140 510(k) submissions under GWF, 11 in the last five years, from 68 different applicants. The average 510(k) review took 163 days (median 139); 103 days on average over the last three years. FDA has posted 16 recalls for GWF devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Electrical, Evoked Response |
| Device class | Class II |
| Regulation | 21 CFR 882.1870 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GWF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 136 |
| 2019 | 1 | 158 |
| 2020 | 1 | 218 |
| 2021 | 2 | 738 |
| 2022 | 2 | 134 |
| 2023 | 2 | 105 |
| 2024 | 4 | 82 |
| 2025 | 1 | 30 |
| 2026 | 2 | 198 |
Compare with all 510(k) review times · Search every GWF clearance
Top GWF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cadwell Laboratories, Inc. | 12 | 2004-11-03 |
| Nihon Kohden America, Inc. | 7 | 2008-10-06 |
| Axon Systems, Inc. | 7 | 2006-11-01 |
| Excel Tech. , Ltd. | 6 | 2004-08-06 |
| Tracor Northern, Inc. | 6 | 1988-12-29 |
63 more applicants have GWF clearances. See the full list in Caduvo.
Most recent GWF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253301 | Time IS Brain, S.L. | BraiN20® (BraiN20) | 2026-06-27 | 271 |
| K252842 | Alphatec Spine, Inc. | SafeOp 3: Neural Informatix System | 2026-01-11 | 125 |
| K243982 | Natus Neurology Incorporated | Nicolet EDX | 2025-01-22 | 30 |
| K243495 | Natus Neurology Incorporated | Natus Ultrapro S100 (982A0594) | 2024-12-12 | 30 |
| K242345 | Quantalx Neuroscience | Delphi Stimulator | 2024-11-05 | 90 |
Recalls for GWF devices
16 product recalls in 12 recall events; 7 initiated in the last five years and 9 still open. Most recent: 2026-05-13.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2022 | 2 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month
Frequently asked questions
What is FDA product code GWF?
GWF is the FDA product code for stimulator, electrical, evoked response. It is a Class II device, regulated under 21 CFR 882.1870 and reviewed by the Neurology panel.
What device class is GWF?
Class II, regulation 21 CFR 882.1870. Typical premarket route: 510(k).
How long does a 510(k) take for product code GWF?
Across 140 cleared submissions the average was 163 days from receipt to decision (median 139).
Which companies have the most GWF clearances?
Cadwell Laboratories, Inc. (12); Nihon Kohden America, Inc. (7); Axon Systems, Inc. (7); Excel Tech. , Ltd. (6); Tracor Northern, Inc. (6).
Have GWF devices been recalled?
Yes: 16 product recalls across 12 recall events; the most recent began 2026-05-13.
Next steps
- Run an FDA pathway report with predicate devices for product code GWF
- Run a recall and safety report across every GWF manufacturer
- Watch product code GWF 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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