Cleared Traditional

K183047 - Nalu Neurostimulation System

K183047 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 140-day FDA review.

K183047 · Boston Scientific Neuromodulation · Neurology device
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Mar 2019
Decision
140d
Days
Class 2
Risk

K183047 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 22, 2019 after a review of 140 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 - K183047

510(k) Number K183047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2018
Decision Date March 22, 2019
Days to Decision 140 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
8d faster than avg
Panel avg: 148d · This submission: 140d
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 K183047.
SandShark Injectable Anchor (SIA) System
K191466 · Stimwave Technologies, Inc. · Nov 2019
Nalu Lead Blank (50cm)
K190960 · Boston Scientific Neuromodulation · Jul 2019
Freedom Spinal Cord Stimulator (SCS) System
K182720 · Stimwave Technologies Incorporated · Mar 2019
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
K180981 · Stimwave Technologies Incorporated · Sep 2018
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base
K172644 · Stimwave Technologies Incorporated · Nov 2017
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
K170141 · Stimwave Technologies Incorporated · May 2017