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

Electrode, Needle

21 CFR 882.1350 / Neurology
FDA source (opens on fda.gov)

GXZ is the FDA product code for Electrode, Needle, a class II device type, regulated under 21 CFR 882.1350. As of , FDA records hold 53 510(k) clearances under this code, the most recent dated , and 21 recalls.

Classification record

Product code
GXZ
Device name
Electrode, Needle
Regulation
21 CFR 882.1350
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
53
Ingested recalls
21

Clearances, product code GXZ

By decision year
53 clearances under product code GXZ with a decision year between 1978 and 2024, 1994 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GXZ by decision year
YearClearances
19781
19851
19872
19891
19903
19922
19931
19944
19952
19961
19981
19992
20001
20011
20023
20031
20041
20053
20062
20073
20082
20101
20112
20121
20132
20142
20161
20192
20201
20232
20241

Applicants with the most clearances

Product code GXZ
Applicants holding the most 510(k) clearances under product code GXZ
ApplicantClearances
Rhythmlink International, LLC5
Cadwell Laboratories, Inc.4
Technomed Europe4
Axon Systems, Inc.2
Class A Ent.2
Ives EEG Solutions2
Medicotest, Inc.2
Neuroinvent, Inc.2
Neurotechnics, Inc.2
The Electrode Store2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 56 companies shown, in name order