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

Stimulator, Peripheral Nerve, Implanted (Pain Relief)

21 CFR 882.5870 / Neurology
FDA source (opens on fda.gov)

GZF is the FDA product code for Stimulator, Peripheral Nerve, Implanted (Pain Relief), a class II device type, regulated under 21 CFR 882.5870. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
GZF
Device name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Regulation
21 CFR 882.5870
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
25
Ingested recalls
7

Clearances, product code GZF

By decision year
25 clearances under product code GZF with a decision year between 1991 and 2026, 2019 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GZF by decision year
YearClearances
19911
19922
19931
19951
19961
19981
20001
20011
20151
20161
20171
20193
20202
20211
20221
20231
20242
20252
20261

Applicants with the most clearances

Product code GZF
Applicants holding the most 510(k) clearances under product code GZF
ApplicantClearances
Medtronic, Inc.8
Bioness, Inc.4
Bioventus LLC2
Boston Scientific Neuromodulation Corporation2
Neuspera Medical, Inc.2
Abbott Medical1
Bioventus, LLC1
Curonix LLC1
Micron Medical Corporation1
Nalu Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order