Cleared Traditional

DSG Connect Technology

K201454 · Spineguard S.A. · Neurology

Feb 2021

Decision

254d

Days

Class 2

Risk

About This 510(k) Submission

K201454 is an FDA 510(k) clearance for the DSG Connect Technology, a Neurosurgical Nerve Locator (Class II — Special Controls, product code PDQ), submitted by Spineguard S.A. (Vincennes, FR). The FDA issued a Cleared decision on February 10, 2021, 254 days after receiving the submission on June 1, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K201454 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2020
Decision Date	February 10, 2021
Days to Decision	254 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.