Cleared Traditional

K161893 - Neuromonitoring Kit

K161893 is the FDA 510(k) clearance for Neuromonitoring Kit by SI-BONE, Inc.. It is a Class 2 Neurology device (product code PDQ) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K161893 · SI-BONE, Inc. · Neurology device
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Oct 2016
Decision
99d
Days
Class 2
Risk

K161893 is an FDA 510(k) clearance for the Neuromonitoring Kit. Classified as Neurosurgical Nerve Locator (product code PDQ), Class II - Special Controls.

Submitted by SI-BONE, Inc. (San Jose, US). The FDA issued a Cleared decision on October 18, 2016 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 874.1820 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all SI-BONE, Inc. devices

Submission Details

510(k) Number K161893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 148d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDQ Neurosurgical Nerve Locator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
Definition To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - PDQ Neurosurgical Nerve Locator

All 23
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