Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
FDA 510(k) K183579 · Boston Scientific Neuromodulation
510(k) numberK183579
Submission
- Device name
- Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
- Applicant
- Boston Scientific Neuromodulation
Valencia, CA, US - Received
- December 21, 2018
- Decision date
- March 29, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K253877 | StimTrial Neuromodulation SystemGZF · Special | Bioventus, LLC | 08/26/2026SE |
| K243782 | StimTrial Neuromodulation SystemGZF · Traditional | Bioventus, LLC | 07/16/2025SE |
| K243678 | TalisMann Neuromodulation SystemGZF · Traditional | Bioventus, LLC | 07/03/2025SE |
| K232415 | Nalu Neurostimulation System for Peripheral Nerve StimulationGZF · Traditional | Boston Scientific Neuromodulation | 08/21/2024SE |
| K233162 | Freedom Peripheral Nerve Stimulator (PNS) SystemGZF · Traditional | Curonix | 06/20/2024SE |
| K221303 | Neuspera Nuity SystemGZF · Traditional | Neuspera Medical, Inc. | 04/11/2023SE |
| K211965 | StimRouter Neuromodulation SystemGZF · Traditional | Bioness, Inc. | 02/23/2022SE |
| K202781 | Neuspera Neurostimulation System (NNS)GZF · Traditional | Neuspera Medical, Inc. | 08/27/2021SE |
| K200848 | Stimulator, Stimulator Kit, External Transmitter, External Transmitter KitGZF · Traditional | Micron Medical Corporation | 08/14/2020SE |
| K200482 | StimRouter Neuromodulation SystemGZF · Special | Bioness, Inc. | 03/27/2020SE |
More from Bioness, Inc.
| 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 |
| K203547 | Nalu Neurostimulation SystemGZB · Traditional | 03/25/2021SE |
| 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 |
| K183047 | Nalu Neurostimulation SystemGZB · Traditional | 03/22/2019SE |
Questions and answers
When was Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits cleared by the FDA?
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits (K183579) received a 510(k) decision of Substantially Equivalent on March 29, 2019, 98 days after the submission was received.
What is the product code of K183579?
The FDA product code is GZF – Stimulator, Peripheral Nerve, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5870.