FDA product code GZQ: Instrument, Dowel Cutting
GZQ is the FDA product code for instrument, dowel cutting. It is a Class II device, regulated under 21 CFR 882.4275 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under GZQ. The average 510(k) review took 210 days (median 210).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Dowel Cutting |
| Device class | Class II |
| Regulation | 21 CFR 882.4275 |
| 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 GZQ clearance
Top GZQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Altoona Medical Supply | 1 | 1989-12-22 |
Most recent GZQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893874 | Altoona Medical Supply | FUJITENS III | 1989-12-22 | 210 |
Recalls for GZQ devices
openFDA lists no recalls for product code GZQ.
Frequently asked questions
What is FDA product code GZQ?
GZQ is the FDA product code for instrument, dowel cutting. It is a Class II device, regulated under 21 CFR 882.4275 and reviewed by the Neurology panel.
What device class is GZQ?
Class II, regulation 21 CFR 882.4275. Typical premarket route: 510(k).
How long does a 510(k) take for product code GZQ?
Across 1 cleared submissions the average was 210 days from receipt to decision (median 210).
Which companies have the most GZQ clearances?
Altoona Medical Supply (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GZQ
- Run a recall and safety report across every GZQ manufacturer
- Watch product code GZQ 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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