FDA product code GWE: Stimulator, Photic, Evoked Response
GWE is the FDA product code for stimulator, photic, evoked response. It is a Class II device, regulated under 21 CFR 882.1890 and reviewed by the Neurology panel. FDA has cleared 49 510(k) submissions under GWE, 2 in the last five years, from 37 different applicants. The average 510(k) review took 178 days (median 115). FDA has posted 3 recalls for GWE devices.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Photic, Evoked Response |
| Device class | Class II |
| Regulation | 21 CFR 882.1890 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GWE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 171 |
| 2020 | 1 | 36 |
| 2021 | 2 | 75 |
| 2022 | 2 | 309 |
Top GWE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Teca, Inc. | 4 | 1988-04-06 |
| Bio-Logic Systems Corp. | 4 | 1988-03-25 |
| Metrovision | 2 | 2022-11-21 |
| Diopsys, Inc. | 2 | 2011-05-09 |
| Excel Tech. , Ltd. | 2 | 2001-10-01 |
32 more applicants have GWE clearances. See the full list in Caduvo.
Most recent GWE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221471 | Diagnosys, LLC | E3 and Profile | 2022-11-22 | 186 |
| K212936 | Metrovision | Vision Monitor- MonCvONE | 2022-11-21 | 432 |
| K211974 | Micromed S.P.A. | LED PHOTIC System | 2021-09-23 | 90 |
| K211643 | Metrovision | Vision Monitor - MonpackONE | 2021-07-26 | 60 |
| K200705 | Cryptych Pty, Ltd. | Nurochek System | 2020-04-23 | 36 |
Recalls for GWE devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-01-02.
Frequently asked questions
What is FDA product code GWE?
GWE is the FDA product code for stimulator, photic, evoked response. It is a Class II device, regulated under 21 CFR 882.1890 and reviewed by the Neurology panel.
What device class is GWE?
Class II, regulation 21 CFR 882.1890. Typical premarket route: 510(k).
How long does a 510(k) take for product code GWE?
Across 49 cleared submissions the average was 178 days from receipt to decision (median 115).
Which companies have the most GWE clearances?
Teca, Inc. (4); Bio-Logic Systems Corp. (4); Metrovision (2); Diopsys, Inc. (2); Excel Tech. , Ltd. (2).
Have GWE devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2015-01-02.
Next steps
- Run an FDA pathway report with predicate devices for product code GWE
- Run a recall and safety report across every GWE manufacturer
- Watch product code GWE 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.