Freedom Peripheral Nerve Stimulator (PNS) System
FDA 510(k) K233162 · Curonix
510(k) numberK233162
Submission
- Device name
- Freedom Peripheral Nerve Stimulator (PNS) System
- Applicant
- Curonix
Pompano Beach, FL, US - Received
- September 27, 2023
- Decision date
- June 20, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GZF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K190047 | StimRouter Neuromodulation SystemGZF · Traditional | Bioness, Inc. | 10/31/2019SE |
Questions and answers
When was Freedom Peripheral Nerve Stimulator (PNS) System cleared by the FDA?
Freedom Peripheral Nerve Stimulator (PNS) System (K233162) received a 510(k) decision of Substantially Equivalent on June 20, 2024, 267 days after the submission was received.
What is the product code of K233162?
The FDA product code is GZF – Stimulator, Peripheral Nerve, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5870.