Cleared Traditional

Neuromonitoring Kit

K161893 · SI-BONE, Inc. · Neurology

Oct 2016

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K161893 is an FDA 510(k) clearance for the Neuromonitoring Kit, a Neurosurgical Nerve Locator (Class II — Special Controls, product code PDQ), submitted by SI-BONE, Inc. (San Jose, US). The FDA issued a Cleared decision on October 18, 2016, 99 days after receiving the submission on July 11, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K161893 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2016
Decision Date	October 18, 2016
Days to Decision	99 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.