Cleared Traditional

Nalu Neurostimulation System

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

About This 510(k) Submission

K203547 is an FDA 510(k) clearance for the Nalu Neurostimulation System, a Stimulator, Spinal-cord, Implanted (pain Relief) (Class II — Special Controls, product code GZB), submitted by Boston Scientific Neuromodulation (Valencia, US). The FDA issued a Cleared decision on March 25, 2021, 111 days after receiving the submission on December 4, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5880.

Submission Details

510(k) Number K203547 FDA.gov
FDA Decision Cleared 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

Device Classification

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

Similar Devices — GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 138
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve 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

More from Boston Scientific...

View all
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
K233801 · GZB · Aug 2024
Nalu Neurostimulation System for Peripheral Nerve Stimulation
K232415 · GZF · Aug 2024
Nalu Neurostimulation System
K221376 · GZB · 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 · GZB · Nov 2020
Nalu Neurostimulation SCS system
K201618 · GZB · Jul 2020