Cleared Traditional

Evala Nerve Stimulator (EPNR002)

K253536 · Epineuron Technologies, Inc. · Ear, Nose, Throat
Feb 2026
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K253536 is an FDA 510(k) clearance for the Evala Nerve Stimulator (EPNR002), a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Epineuron Technologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on February 27, 2026, 106 days after receiving the submission on November 13, 2025. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K253536 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2025
Decision Date February 27, 2026
Days to Decision 106 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
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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