Nalu Neurostimulation System
FDA 510(k) K203547 · Boston Scientific Neuromodulation
510(k) numberK203547
Submission
- Device name
- Nalu Neurostimulation System
- Applicant
- Boston Scientific Neuromodulation
Valencia, CA, US - Received
- December 4, 2020
- Decision date
- March 25, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GZB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System…GZB · Traditional | Boston Scientific Neuromodulation | 08/23/2024SE |
| K221376 | Nalu Neurostimulation SystemGZB · Special | Boston Scientific Neuromodulation | 06/10/2022SE |
| K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit…GZB · Traditional | Boston Scientific Neuromodulation | 11/09/2020SE |
| K201618 | Nalu Neurostimulation SCS systemGZB · Special | Boston Scientific Neuromodulation | 07/15/2020SE |
| K191466 | SandShark Injectable Anchor (SIA) SystemGZB · Traditional | Stimwave Technologies, Inc. | 11/07/2019SE |
| K190960 | Nalu Lead Blank (50cm)GZB · Traditional | Boston Scientific Neuromodulation | 07/11/2019SE |
| K182720 | Freedom Spinal Cord Stimulator (SCS) SystemGZB · Traditional | Stimwave Technologies Incorporated | 03/29/2019SE |
| K183047 | Nalu Neurostimulation SystemGZB · Traditional | Boston Scientific Neuromodulation | 03/22/2019SE |
| K180981 | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitGZB · Traditional | Stimwave Technologies Incorporated | 09/19/2018SE |
| K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading…GZB · Traditional | Stimwave Technologies Incorporated | 11/03/2017SE |
More from Stimwave Technologies Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K251247 | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit…GXD · Traditional | 08/07/2025SE |
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System…GZB · Traditional | 08/23/2024SE |
| K232415 | Nalu Neurostimulation System for Peripheral Nerve StimulationGZF · Traditional | 08/21/2024SE |
| K221376 | Nalu Neurostimulation SystemGZB · Special | 06/10/2022SE |
| K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit…GZB · Traditional | 11/09/2020SE |
| K201618 | Nalu Neurostimulation SCS systemGZB · Special | 07/15/2020SE |
| K190960 | Nalu Lead Blank (50cm)GZB · Traditional | 07/11/2019SE |
| K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation…GZF · Traditional | 03/29/2019SE |
| K183047 | Nalu Neurostimulation SystemGZB · Traditional | 03/22/2019SE |
Questions and answers
When was Nalu Neurostimulation System cleared by the FDA?
Nalu Neurostimulation System (K203547) received a 510(k) decision of Substantially Equivalent on March 25, 2021, 111 days after the submission was received.
What is the product code of K203547?
The FDA product code is GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5880.