FDA product code GZP: Stimulator, Mechanical, Evoked Response
GZP is the FDA product code for stimulator, mechanical, evoked response. It is a Class II device, regulated under 21 CFR 882.1880 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under GZP, from 2 different applicants. The average 510(k) review took 142 days (median 142).
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Mechanical, Evoked Response |
| Device class | Class II |
| Regulation | 21 CFR 882.1880 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GZP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 167 |
Compare with all 510(k) review times · Search every GZP clearance
Top GZP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Blinktbi, Inc. | 1 | 2019-12-09 |
| Biomagnetic Technologies, Inc. | 1 | 1991-12-09 |
Most recent GZP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191700 | Blinktbi, Inc. | EyeStat | 2019-12-09 | 167 |
| K913604 | Biomagnetic Technologies, Inc. | SOMATOSENSORY STIMULUS SYSTEM | 1991-12-09 | 117 |
Recalls for GZP devices
openFDA lists no recalls for product code GZP.
Frequently asked questions
What is FDA product code GZP?
GZP is the FDA product code for stimulator, mechanical, evoked response. It is a Class II device, regulated under 21 CFR 882.1880 and reviewed by the Neurology panel.
What device class is GZP?
Class II, regulation 21 CFR 882.1880. Typical premarket route: 510(k).
How long does a 510(k) take for product code GZP?
Across 2 cleared submissions the average was 142 days from receipt to decision (median 142).
Which companies have the most GZP clearances?
Blinktbi, Inc. (1); Biomagnetic Technologies, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GZP
- Run a recall and safety report across every GZP manufacturer
- Watch product code GZP 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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