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

Stimulator, Nerve

21 CFR 874.1820 / Ear, Nose, Throat
FDA source (opens on fda.gov)

ETN is the FDA product code for Stimulator, Nerve, a class II device type, regulated under 21 CFR 874.1820. As of , FDA records hold 97 510(k) clearances under this code, the most recent dated , and 31 recalls.

Classification record

Product code
ETN
Device name
Stimulator, Nerve
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
97
Ingested recalls
31

Clearances, product code ETN

By decision year
97 clearances under product code ETN with a decision year between 1978 and 2026, 2011 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code ETN by decision year
YearClearances
19781
19831
19841
19851
19873
19883
19891
19902
19912
19923
19932
19943
19953
19973
19982
19992
20001
20012
20023
20033
20041
20053
20063
20072
20082
20095
20103
20119
20127
20131
20142
20151
20162
20201
20211
20222
20235
20242
20251
20262

Applicants with the most clearances

Product code ETN
Applicants holding the most 510(k) clearances under product code ETN
ApplicantClearances
Medtronic Xomed, Inc.10
Magstim Inc.9
NuVasive Inc6
Inomed Medizintechnik GmbH5
Neurovision Medical Products Inc5
Rln Systems, Inc.5
Baxano, Inc.3
Ndi Medical, LLC3
Uromed Corp.3
Apyx Medical Corporation2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 119 companies shown, in name order