FDA product code GXZ: Electrode, Needle
GXZ is the FDA product code for electrode, needle. It is a Class II device, regulated under 21 CFR 882.1350 and reviewed by the Neurology panel. FDA has cleared 53 510(k) submissions under GXZ, 3 in the last five years, from 36 different applicants. The average 510(k) review took 194 days (median 140); 238 days on average over the last three years. FDA has posted 21 recalls for GXZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Needle |
| Device class | Class II |
| Regulation | 21 CFR 882.1350 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GXZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 83 |
| 2020 | 1 | 43 |
| 2023 | 2 | 60 |
| 2024 | 1 | 238 |
Compare with all 510(k) review times · Search every GXZ clearance
Top GXZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rhythmlink International, LLC | 5 | 2020-05-27 |
| Technomed Europe | 4 | 2024-12-11 |
| Cadwell Laboratories, Inc. | 4 | 1994-12-29 |
| Neuroinvent, Inc. | 2 | 2014-11-05 |
| Axon Systems, Inc. | 2 | 2007-01-12 |
31 more applicants have GXZ clearances. See the full list in Caduvo.
Most recent GXZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241045 | Technomed Europe | Disposable Subdermal Needle Electrode, Corkscrew | 2024-12-11 | 238 |
| K232581 | Suzhou Haishen Medical Device Associates Co., Ltd. | Medical Disposable Sterile Needle Electrode | 2023-12-04 | 101 |
| K231691 | TeDan Surgical Innovations, Inc. | Phantom XL Insulated Dilators | 2023-06-29 | 20 |
| K200984 | Rhythmlink International, LLC | Guardian Needle Electrode | 2020-05-27 | 43 |
| K192603 | Spes Medica Srl | Spes Medica Subdermal Needle Electrodes | 2019-11-22 | 63 |
Recalls for GXZ devices
21 product recalls in 3 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2021-12-08.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code GXZ?
GXZ is the FDA product code for electrode, needle. It is a Class II device, regulated under 21 CFR 882.1350 and reviewed by the Neurology panel.
What device class is GXZ?
Class II, regulation 21 CFR 882.1350. Typical premarket route: 510(k).
How long does a 510(k) take for product code GXZ?
Across 53 cleared submissions the average was 194 days from receipt to decision (median 140).
Which companies have the most GXZ clearances?
Rhythmlink International, LLC (5); Technomed Europe (4); Cadwell Laboratories, Inc. (4); Neuroinvent, Inc. (2); Axon Systems, Inc. (2).
Have GXZ devices been recalled?
Yes: 21 product recalls across 3 recall events; the most recent began 2021-12-08.
Next steps
- Run an FDA pathway report with predicate devices for product code GXZ
- Run a recall and safety report across every GXZ manufacturer
- Watch product code GXZ 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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