FDA product code GZK: Electrode, Nasopharyngeal
GZK is the FDA product code for electrode, nasopharyngeal. It is a Class II device, regulated under 21 CFR 882.1340 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under GZK, from 2 different applicants. The average 510(k) review took 96 days (median 96).
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Nasopharyngeal |
| Device class | Class II |
| Regulation | 21 CFR 882.1340 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GZK clearance
Top GZK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Viasys Healthcare, Inc. | 1 | 2003-08-01 |
| Bertone & Assoc. | 1 | 1983-03-01 |
Most recent GZK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K030517 | Viasys Healthcare, Inc. | BALL RECORDING ELECTRODE/STIMULATION PROBE | 2003-08-01 | 163 |
| K830325 | Bertone & Assoc. | TIGER PULSE | 1983-03-01 | 28 |
Recalls for GZK devices
openFDA lists no recalls for product code GZK.
Frequently asked questions
What is FDA product code GZK?
GZK is the FDA product code for electrode, nasopharyngeal. It is a Class II device, regulated under 21 CFR 882.1340 and reviewed by the Neurology panel.
What device class is GZK?
Class II, regulation 21 CFR 882.1340. Typical premarket route: 510(k).
How long does a 510(k) take for product code GZK?
Across 2 cleared submissions the average was 96 days from receipt to decision (median 96).
Which companies have the most GZK clearances?
Viasys Healthcare, Inc. (1); Bertone & Assoc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GZK
- Run a recall and safety report across every GZK manufacturer
- Watch product code GZK 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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