Cleared Traditional

PEDIGUARD NERVE DETECTOR SYSTEM

K123390 · Spineguard S.A. · Neurology

Aug 2013

Decision

279d

Days

Class 2

Risk

About This 510(k) Submission

K123390 is an FDA 510(k) clearance for the PEDIGUARD NERVE DETECTOR SYSTEM, a Neurosurgical Nerve Locator (Class II — Special Controls, product code PDQ), submitted by Spineguard S.A. (Washington, US). The FDA issued a Cleared decision on August 8, 2013, 279 days after receiving the submission on November 2, 2012. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K123390 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2012
Decision Date	August 08, 2013
Days to Decision	279 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement

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.