Cleared Traditional

EARP Nerve Cuff Electrode

K230853 · Nvision Biomedical Technologies, Inc. · Neurology
Oct 2023
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K230853 is an FDA 510(k) clearance for the EARP Nerve Cuff Electrode, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Nvision Biomedical Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on October 6, 2023, 192 days after receiving the submission on March 28, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K230853 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2023
Decision Date October 06, 2023
Days to Decision 192 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code ETN — Stimulator, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1820

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