GZF — Stimulator, Peripheral Nerve, Implanted (Pain Relief) Class II
FDA product code GZF covers "Stimulator, Peripheral Nerve, Implanted (Pain Relief)", a Class II medical device regulated under 21 CFR 882.5870. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GZF
- Device Class
- Class II
- Regulation Number
- 882.5870
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243782 | bioventus | StimTrial Neuromodulation System | July 16, 2025 |
| K243678 | bioventus | TalisMann Neuromodulation System | July 3, 2025 |
| K232415 | boston scientific neuromodulation | Nalu Neurostimulation System for Peripheral Nerve Stimulation | August 21, 2024 |
| K233162 | curonix | Freedom Peripheral Nerve Stimulator (PNS) System | June 20, 2024 |
| K221303 | neuspera medical | Neuspera Nuity System | April 11, 2023 |
| K211965 | bioness | StimRouter Neuromodulation System | February 23, 2022 |
| K202781 | neuspera medical | Neuspera Neurostimulation System (NNS) | August 27, 2021 |
| K200848 | micron medical corporation | Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit | August 14, 2020 |
| K200482 | bioness | StimRouter Neuromodulation System | March 27, 2020 |
| K190047 | bioness | StimRouter Neuromodulation System | October 31, 2019 |
| K191435 | nalu medical | IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4 | September 6, 2019 |
| K183579 | boston scientific neuromodulation | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimul | March 29, 2019 |
| K171366 | stimwave technologies inc., dba stimq | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Ac | August 4, 2017 |
| K152178 | stimq | StimQ Peripheral Nerve Stimulator (PNS) System | March 11, 2016 |
| K142432 | bioness | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRo | February 20, 2015 |
| K000852 | advanced neuromodulation systems | RENEW NEUROSTIMULATION SYSTEM | January 19, 2001 |
| K000105 | medtronic vascular | MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EX | April 12, 2000 |
| K982902 | medtronic vascular | PERIPHERAL NERVE STIMULATION | November 10, 1998 |
| K960631 | medtronic vascular | MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX | May 21, 1996 |
| K950425 | medtronic vascular | TECOTHANE 55D | April 19, 1995 |