Cleared Traditional

PediGuard Threaded

K220160 · Spineguard S.A. · Neurology

Mar 2022

Decision

71d

Days

Class 2

Risk

About This 510(k) Submission

K220160 is an FDA 510(k) clearance for the PediGuard Threaded, 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 March 31, 2022, 71 days after receiving the submission on January 19, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K220160 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 2022
Decision Date	March 31, 2022
Days to Decision	71 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.