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

FDA 510(k) K233801 · Boston Scientific Neuromodulation

Substantially Equivalent

510(k) numberK233801

Submission

Device name
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
Applicant
Boston Scientific Neuromodulation
Valencia, CA, US
Received
November 29, 2023
Decision date
August 23, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5880
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code GZB

510(k)DeviceApplicantDecision
K221376Nalu Neurostimulation SystemGZB · Special Boston Scientific Neuromodulation06/10/2022SE
K203547Nalu Neurostimulation SystemGZB · Traditional Boston Scientific Neuromodulation03/25/2021SE
K202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit…GZB · Traditional Boston Scientific Neuromodulation11/09/2020SE
K201618Nalu Neurostimulation SCS systemGZB · Special Boston Scientific Neuromodulation07/15/2020SE
K191466SandShark Injectable Anchor (SIA) SystemGZB · Traditional Stimwave Technologies, Inc.11/07/2019SE
K190960Nalu Lead Blank (50cm)GZB · Traditional Boston Scientific Neuromodulation07/11/2019SE
K182720Freedom Spinal Cord Stimulator (SCS) SystemGZB · Traditional Stimwave Technologies Incorporated03/29/2019SE
K183047Nalu Neurostimulation SystemGZB · Traditional Boston Scientific Neuromodulation03/22/2019SE
K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitGZB · Traditional Stimwave Technologies Incorporated09/19/2018SE
K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading…GZB · Traditional Stimwave Technologies Incorporated11/03/2017SE

More from Stimwave Technologies Incorporated

510(k)DeviceDecision
K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit…GXD · Traditional 08/07/2025SE
K232415Nalu Neurostimulation System for Peripheral Nerve StimulationGZF · Traditional 08/21/2024SE
K221376Nalu Neurostimulation SystemGZB · Special 06/10/2022SE
K203547Nalu Neurostimulation SystemGZB · Traditional 03/25/2021SE
K202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit…GZB · Traditional 11/09/2020SE
K201618Nalu Neurostimulation SCS systemGZB · Special 07/15/2020SE
K190960Nalu Lead Blank (50cm)GZB · Traditional 07/11/2019SE
K183579Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation…GZF · Traditional 03/29/2019SE
K183047Nalu Neurostimulation SystemGZB · Traditional 03/22/2019SE

Questions and answers

When was Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation cleared by the FDA?

Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation (K233801) received a 510(k) decision of Substantially Equivalent on August 23, 2024, 268 days after the submission was received.

What is the product code of K233801?

The FDA product code is GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5880.