Cleared Special

K221376 - Nalu Neurostimulation System

K221376 is an FDA 510(k) clearance for Nalu Neurostimulation System, manufactured by Boston Scientific Neuromodulation. The device is a Class 2 Neurology device with product code GZB cleared through the Special 510(k) pathway after a 29-day FDA review.

K221376 · Boston Scientific Neuromodulation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
29d
Days
Class 2
Risk

K221376 is an FDA 510(k) clearance for the Nalu Neurostimulation 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 June 10, 2022 after a review of 29 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.

FDA 510(k) Submission Details - K221376

510(k) Number K221376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2022
Decision Date June 10, 2022
Days to Decision 29 days
Submission Type Special
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
120d faster than avg
Panel avg: 149d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

GZB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 138
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K221376.
Nalu Neurostimulation System for Spinal Cord Stimulation
K233801 · Boston Scientific Neuromodulation · Aug 2024
Nalu Neurostimulation System
K203547 · Boston Scientific Neuromodulation · Mar 2021
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
K202274 · Boston Scientific Neuromodulation · Nov 2020
Nalu Neurostimulation SCS system
K201618 · Boston Scientific Neuromodulation · Jul 2020
SandShark Injectable Anchor (SIA) System
K191466 · Stimwave Technologies, Inc. · Nov 2019
Nalu Lead Blank (50cm)
K190960 · Boston Scientific Neuromodulation · Jul 2019
K221376 · Nalu Neurostimulation System
Download PDF FDA Summary Boston Scientific Neu…