510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GWJClass II

Stimulator, Auditory, Evoked Response

21 CFR 882.1900 / Neurology
FDA source (opens on fda.gov)

GWJ is the FDA product code for Stimulator, Auditory, Evoked Response, a class II device type, regulated under 21 CFR 882.1900. As of , FDA records hold 76 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
GWJ
Device name
Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
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
76
Ingested recalls
4

Clearances, product code GWJ

By decision year
76 clearances under product code GWJ with a decision year between 1977 and 2024, 1981 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GWJ by decision year
YearClearances
19772
19782
19791
19814
19821
19832
19851
19863
19874
19881
19913
19921
19932
19953
19971
19981
19994
20001
20013
20024
20033
20041
20051
20061
20072
20084
20094
20101
20112
20121
20132
20142
20151
20172
20201
20211
20221
20242

Applicants with the most clearances

Product code GWJ
Applicants holding the most 510(k) clearances under product code GWJ
ApplicantClearances
Bio-Logic Systems Corp.11
Intelligent Hearing Systems Corp.8
Natus Medical Denmark ApS5
Path Medical GmbH4
Amplaid USA, Inc.3
Interacoustics a/S3
Micro-Shev, Ltd.3
Vivosonic Inc.3
Cadwell Laboratories, Inc.2
Grason-Stadler, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 57 companies shown, in name order