Cleared Traditional

Neurosign V4 Intraoperative Nerve Monitor

K203684 · Magstim Company, Ltd. · Neurology

Mar 2021

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K203684 is an FDA 510(k) clearance for the Neurosign V4 Intraoperative Nerve Monitor, a Neurosurgical Nerve Locator (Class II — Special Controls, product code PDQ), submitted by Magstim Company, Ltd. (Whitland, GB). The FDA issued a Cleared decision on March 17, 2021, 90 days after receiving the submission on December 17, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K203684 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 2020
Decision Date	March 17, 2021
Days to Decision	90 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.