Cleared Traditional

Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits (K183579) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183579 · Boston Scientific Neuromodulation · Neurology device
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Mar 2019
Decision
98d
Days
Class 2
Risk

K183579 is an FDA 510(k) clearance for the Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurosti.... Classified as Stimulator, Peripheral Nerve, Implanted (pain Relief) (product code GZF), Class II - Special Controls.

Submitted by Boston Scientific Neuromodulation (Valencia, US). The FDA issued a Cleared decision on March 29, 2019 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5870 - 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 Boston Scientific Neuromodulation devices

Submission Details

510(k) Number K183579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2018
Decision Date March 29, 2019
Days to Decision 98 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 148d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZF Stimulator, Peripheral Nerve, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5870
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 - GZF Stimulator, Peripheral Nerve, Implanted (pain Relief)

All 23
Devices cleared under the same product code (GZF) and FDA review panel - the closest regulatory comparables to K183579.
StimTrial Neuromodulation System
K243782 · Bioventus, LLC · Jul 2025
TalisMann Neuromodulation System
K243678 · Bioventus, LLC · Jul 2025
Nalu Neurostimulation System for Peripheral Nerve Stimulation
K232415 · Boston Scientific Neuromodulation · Aug 2024
Freedom Peripheral Nerve Stimulator (PNS) System
K233162 · Curonix · Jun 2024
Neuspera Nuity System
K221303 · Neuspera Medical, Inc. · Apr 2023
StimRouter Neuromodulation System
K211965 · Bioness, Inc. · Feb 2022