Cleared Special

K201618 - Nalu Neurostimulation SCS system (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201618 · Boston Scientific Neuromodulation · Neurology device
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Jul 2020
Decision
30d
Days
Class 2
Risk

K201618 is an FDA 510(k) clearance for the Nalu Neurostimulation SCS system. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Boston Scientific Neuromodulation (Valencia, US). The FDA issued a Cleared decision on July 15, 2020 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Neuromodulation devices

Submission Details

510(k) Number K201618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2020
Decision Date July 15, 2020
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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.