Cleared Traditional

Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip ?4.0mm, PediGuard Tri Tip ?3.2mm, PediGuard Tri Tip ?2.5mm, PediGuard ?2.5mm XS, PediGuard Curv, PediGuard Curv XS

K143159 · Spineguard S.A. · Neurology

Jan 2015

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K143159 is an FDA 510(k) clearance for the Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip ?4.0mm, PediGuard Tri Tip ?3.2mm, PediGuard Tri Tip ?2.5mm, PediGuard ?2.5mm XS, PediGuard Curv, PediGuard Curv XS, a Neurosurgical Nerve Locator (Class II — Special Controls, product code PDQ), submitted by Spineguard S.A. (Saint Mande, FR). The FDA issued a Cleared decision on January 23, 2015, 81 days after receiving the submission on November 3, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K143159 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 2014
Decision Date	January 23, 2015
Days to Decision	81 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.