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

Electrode, Depth

21 CFR 882.1330 / Neurology
FDA source (opens on fda.gov)

GZL is the FDA product code for Electrode, Depth, a class II device type, regulated under 21 CFR 882.1330. As of , FDA records hold 58 510(k) clearances under this code, the most recent dated , and 24 recalls.

Classification record

Product code
GZL
Device name
Electrode, Depth
Regulation
21 CFR 882.1330
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
58
Ingested recalls
24

Clearances, product code GZL

By decision year
58 clearances under product code GZL with a decision year between 1980 and 2026, 2004 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GZL by decision year
YearClearances
19803
19861
19891
19901
19952
19973
19983
19992
20002
20011
20044
20053
20062
20073
20091
20111
20121
20131
20141
20162
20174
20183
20201
20213
20223
20233
20252
20261

Applicants with the most clearances

Product code GZL
Applicants holding the most 510(k) clearances under product code GZL
ApplicantClearances
AD-Tech Medical Instrument Corp.13
Alpha Omega Engineering Ltd.8
Alpha Omega, Ltd.3
PMT Corp.3
Progress Mankind Technology3
Dixi Medical2
FHC, Inc.2
FHC, Inc.2
Ice Neurosystems, Inc.2
Neuroone Medical Technologies Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order