Cleared Special

EARP Nerve Cuff Electrode

K241917 · Retropsoas Technologies, LLC · Neurology
Jul 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K241917 is an FDA 510(k) clearance for the EARP Nerve Cuff Electrode, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Retropsoas Technologies, LLC (Frontenac, US). The FDA issued a Cleared decision on July 31, 2024, 30 days after receiving the submission on July 1, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K241917 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2024
Decision Date July 31, 2024
Days to Decision 30 days
Submission Type Special
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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