Cleared Traditional

RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE

K132138 · Rhythmlink International, LLC · Neurology

Apr 2014

Decision

274d

Days

Class 2

Risk

About This 510(k) Submission

K132138 is an FDA 510(k) clearance for the RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE, a Neurosurgical Nerve Locator (Class II — Special Controls, product code PDQ), submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on April 11, 2014, 274 days after receiving the submission on July 11, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K132138 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2013
Decision Date	April 11, 2014
Days to Decision	274 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.