FDA product code GWX: Fork, Tuning
GWX is the FDA product code for fork, tuning. It is a Class I device, regulated under 21 CFR 882.1525 and reviewed by the Neurology panel. FDA has cleared 4 510(k) submissions under GWX, from 3 different applicants. The average 510(k) review took 28 days (median 25).
Classification
| Field | Value |
|---|---|
| Device name | Fork, Tuning |
| Device class | Class I |
| Regulation | 21 CFR 882.1525 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every GWX clearance
Top GWX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 2 | 1976-12-02 |
| Solway, Inc. | 1 | 1988-01-04 |
| Conphar, Inc. | 1 | 1981-12-10 |
Most recent GWX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874966 | Solway, Inc. | TUNING FORKS | 1988-01-04 | 33 |
| K813304 | Conphar, Inc. | CONPHAR, TUNING FORKS | 1981-12-10 | 17 |
| K761132 | Fred Sammons, Inc. | TUNING FORK | 1976-12-02 | 13 |
| K760303 | Fred Sammons, Inc. | FORK, TUNING BK-7519 | 1976-09-08 | 47 |
Recalls for GWX devices
openFDA lists no recalls for product code GWX.
Frequently asked questions
What is FDA product code GWX?
GWX is the FDA product code for fork, tuning. It is a Class I device, regulated under 21 CFR 882.1525 and reviewed by the Neurology panel.
What device class is GWX?
Class I, regulation 21 CFR 882.1525. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GWX?
Across 4 cleared submissions the average was 28 days from receipt to decision (median 25).
Which companies have the most GWX clearances?
Fred Sammons, Inc. (2); Solway, Inc. (1); Conphar, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GWX
- Run a recall and safety report across every GWX manufacturer
- Watch product code GWX 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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