Cleared Traditional

K250094 - Atlas Stim Headbox (NK) (31-0601-0077) (FDA 510(k) Clearance)

Also includes:
Atlas Stim Headbox (Touchproof) (31-0601-0089) Atlas Stim Headbox (HD) (31-0601-0132) ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001) ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002) ATLAS Stim Headbox Software (36-0301-0006) Atlas Headbox Interface Cable (NK) (31-0204-003) Atlas Headbox Interface Cable (Touchproof) (31-0204-004) Atlas Headbox Interface Cable (HD) (31-0204-005) Atlas Headbox Expansion Panel (31-0607-0014)
K250094 · Neuralynx, Inc. · Neurology device
Apr 2025
Decision
90d
Days
Class 2
Risk

K250094 is an FDA 510(k) clearance for the Atlas Stim Headbox (NK) (31-0601-0077). This device is classified as a Electrode, Cortical (Class II - Special Controls, product code GYC).

Submitted by Neuralynx, Inc. (Bozeman, US). The FDA issued a Cleared decision on April 14, 2025, 90 days after receiving the submission on January 14, 2025.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1310.

Submission Details

510(k) Number K250094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2025
Decision Date April 14, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GYC - Electrode, Cortical
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.1310