FDA product code GWY: Pinwheel
GWY is the FDA product code for pinwheel. It is a Class I device, regulated under 21 CFR 882.1750 and reviewed by the Neurology panel. FDA has cleared 5 510(k) submissions under GWY, from 5 different applicants. The average 510(k) review took 26 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Pinwheel |
| Device class | Class I |
| Regulation | 21 CFR 882.1750 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GWY clearance
Top GWY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aspect Medical Systems, Inc. | 1 | 2005-02-24 |
| Burke Neutech, Inc. | 1 | 1994-08-03 |
| Dexin Pty. , Ltd. | 1 | 1987-04-01 |
| Artiberia | 1 | 1985-06-13 |
| Projects IN Health | 1 | 1978-04-04 |
Most recent GWY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050313 | Aspect Medical Systems, Inc. | BIS SRS (SEMI-RESUABLE SENSOR) | 2005-02-24 | 15 |
| K942926 | Burke Neutech, Inc. | NEURO-AIDE | 1994-08-03 | 42 |
| K871167 | Dexin Pty. , Ltd. | SENSITESTER | 1987-04-01 | 8 |
| K851749 | Artiberia | 1-380 PINWHEEL (WARTENBERG) | 1985-06-13 | 49 |
| K780422 | Projects IN Health | PINWHEEL | 1978-04-04 | 18 |
Recalls for GWY devices
openFDA lists no recalls for product code GWY.
Frequently asked questions
What is FDA product code GWY?
GWY is the FDA product code for pinwheel. It is a Class I device, regulated under 21 CFR 882.1750 and reviewed by the Neurology panel.
What device class is GWY?
Class I, regulation 21 CFR 882.1750. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GWY?
Across 5 cleared submissions the average was 26 days from receipt to decision (median 18).
Which companies have the most GWY clearances?
Aspect Medical Systems, Inc. (1); Burke Neutech, Inc. (1); Dexin Pty. , Ltd. (1); Artiberia (1); Projects IN Health (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GWY
- Run a recall and safety report across every GWY manufacturer
- Watch product code GWY 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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