Cleared Traditional

NeuroEars-Anna?

K243709 · Neuroears, Inc. · Ear, Nose, Throat

Aug 2025

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K243709 is an FDA 510(k) clearance for the NeuroEars-Anna?, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Neuroears, Inc. (Gangwon-Do, KR). The FDA issued a Cleared decision on August 25, 2025, 266 days after receiving the submission on December 2, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number	K243709 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2024
Decision Date	August 25, 2025
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF