GZF · Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Neurology · 21 CFR 882.5870 · Class 2
Overview
| Product Code | GZF |
|---|---|
| Device Name | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Regulation | 21 CFR 882.5870 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 25)
Showing 20 most recent of 25 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240974 | SPRINT PNS System | Spr Therapeutics, Inc. | Apr 14, 2026 | SESE |
| K243782 | StimTrial Neuromodulation System | Bioventus, LLC | Jul 16, 2025 | SESE |
| K243678 | TalisMann Neuromodulation System | Bioventus, LLC | Jul 3, 2025 | SESE |
| K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation | Aug 21, 2024 | SESE |
| K233162 | Freedom Peripheral Nerve Stimulator (PNS) System | Curonix | Jun 20, 2024 | SESE |
| K221303 | Neuspera Nuity System | Neuspera Medical, Inc. | Apr 11, 2023 | SESE |
| K211965 | StimRouter Neuromodulation System | Bioness, Inc. | Feb 23, 2022 | SESE |
| K202781 | Neuspera Neurostimulation System (NNS) | Neuspera Medical, Inc. | Aug 27, 2021 | SESE |
| K200848 | Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit | Micron Medical Corporation | Aug 14, 2020 | SESE |
| K200482 | StimRouter Neuromodulation System | Bioness, Inc. | Mar 27, 2020 | SESE |
| K190047 | StimRouter Neuromodulation System | Bioness, Inc. | Oct 31, 2019 | SESE |
| K191435 | IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 | Nalu Medical, Inc. | Sep 6, 2019 | SESE |
| K183579 | 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 | Boston Scientific Neuromodulation | Mar 29, 2019 | SESE |
| K171366 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit | Stimwave Technologies Inc., Dba Stimq, LLC | Aug 4, 2017 | SESE |
| K152178 | StimQ Peripheral Nerve Stimulator (PNS) System | Stimq, LLC | Mar 11, 2016 | SESE |
| K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit | Bioness, Inc. | Feb 20, 2015 | SESE |
| K000852 | RENEW NEUROSTIMULATION SYSTEM | Advanced Neuromodulation Systems | Jan 19, 2001 | SESE |
| K000105 | MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), | Medtronic Vascular | Apr 12, 2000 | SESE |
| K982902 | PERIPHERAL NERVE STIMULATION | Medtronic Vascular | Nov 10, 1998 | SESE |
| K960631 | MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX | Medtronic Vascular | May 21, 1996 | SESE |
Top Applicants
- Medtronic Vascular — 8 clearances
- Bioness, Inc. — 4 clearances
- Bioventus, LLC — 2 clearances
- Boston Scientific Neuromodulation — 2 clearances
- Neuspera Medical, Inc. — 2 clearances
