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FDA PRODUCT CODE · CLASS II

ETN — Stimulator, Nerve

DEVICE CLASS
Class II
REGULATION
21 CFR 874.1820
MEDICAL SPECIALTY
Ear, Nose, Throat
REVIEW PANEL
EN
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K253536Epineuron Technologies, Inc. · 510k2026-02-27
K251672Medtronic Xomed, Inc. · 510k2026-02-10
K242852Inomed Medizintechnik GmbH · 510k2025-06-13
K233001Biosys Biyomedikal Muhendislik San. VE Tic. A.S. · 510k2024-12-13

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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