510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
GWEClass II

Stimulator, Photic, Evoked Response

21 CFR 882.1890 / Neurology
FDA source (opens on fda.gov)

GWE is the FDA product code for Stimulator, Photic, Evoked Response, a class II device type, regulated under 21 CFR 882.1890. As of , FDA records hold 49 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
GWE
Device name
Stimulator, Photic, Evoked Response
Regulation
21 CFR 882.1890
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
49
Ingested recalls
3

Clearances, product code GWE

By decision year
49 clearances under product code GWE with a decision year between 1978 and 2022, 1985 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GWE by decision year
YearClearances
19782
19793
19801
19812
19833
19843
19854
19864
19872
19882
19891
19911
19951
19981
19991
20001
20011
20031
20041
20052
20091
20101
20111
20122
20151
20181
20201
20212
20222

Applicants with the most clearances

Product code GWE
Applicants holding the most 510(k) clearances under product code GWE
ApplicantClearances
Bio-Logic Systems Corp.4
Cadwell Laboratories, Inc.2
Diopsys Inc2
Excel Tech., Ltd.2
Metrovision2
Nihon Kohden America Inc2
Teca, Inc.2
Tracor Northern, Inc.2
Airsep Corp.1
Amplaid USA, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 38 companies shown, in name order