Cleared Traditional

Neuralytix iD3 System (NTX-9001)

K243636 · Neuralytix, LLC · Neurology

Jun 2025

Decision

213d

Days

Class 2

Risk

About This 510(k) Submission

K243636 is an FDA 510(k) clearance for the Neuralytix iD3 System (NTX-9001), a Neurosurgical Nerve Locator (Class II — Special Controls, product code PDQ), submitted by Neuralytix, LLC (Fruita, US). The FDA issued a Cleared decision on June 26, 2025, 213 days after receiving the submission on November 25, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K243636 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2024
Decision Date	June 26, 2025
Days to Decision	213 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	PDQ — Neurosurgical Nerve Locator
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.1820
Definition	To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.