Cleared Traditional

ALARA Neuro Access Kit

K190163 · SurGenTec, LLC · Neurology

Jul 2019

Decision

166d

Days

Class 2

Risk

About This 510(k) Submission

K190163 is an FDA 510(k) clearance for the ALARA Neuro Access Kit, a Neurosurgical Nerve Locator (Class II — Special Controls, product code PDQ), submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on July 16, 2019, 166 days after receiving the submission on January 31, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K190163 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2019
Decision Date	July 16, 2019
Days to Decision	166 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.