Cleared Traditional

K203547 - Nalu Neurostimulation System

K203547 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 Traditional 510(k) pathway after a 111-day FDA review.

K203547 · Boston Scientific Neuromodulation · Neurology device
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Mar 2021
Decision
111d
Days
Class 2
Risk

K203547 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 March 25, 2021 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - 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

FDA 510(k) Submission Details - K203547

510(k) Number K203547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2020
Decision Date March 25, 2021
Days to Decision 111 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
37d faster than avg
Panel avg: 148d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 117
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K203547.
Nalu Neurostimulation System for Spinal Cord Stimulation
K233801 · Boston Scientific Neuromodulation · Aug 2024
Nalu Neurostimulation System
K221376 · Boston Scientific Neuromodulation · Jun 2022
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