Product code GZF
- Device name
- Stimulator, Peripheral Nerve, Implanted (Pain Relief)
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5870
- Review panel
- NE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243782 | StimTrial Neuromodulation System | Bioventus, LLC | 2025-07-16 |
| K243678 | TalisMann Neuromodulation System | Bioventus, LLC | 2025-07-03 |
| K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation | 2024-08-21 |
| K233162 | Freedom Peripheral Nerve Stimulator (PNS) System | Curonix | 2024-06-20 |
| K221303 | Neuspera Nuity System | Neuspera Medical, Inc. | 2023-04-11 |
| K211965 | StimRouter Neuromodulation System | Bioness, Inc. | 2022-02-23 |
| K202781 | Neuspera Neurostimulation System (NNS) | Neuspera Medical, Inc. | 2021-08-27 |
| K200848 | Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit | Micron Medical Corporation | 2020-08-14 |
| K200482 | StimRouter Neuromodulation System | Bioness, Inc. | 2020-03-27 |
| K190047 | StimRouter Neuromodulation System | Bioness, Inc. | 2019-10-31 |
| K191435 | IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 | Nalu Medical, Inc. | 2019-09-06 |
| 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 Kit... | Boston Scientific Neuromodulation | 2019-03-29 |
| K171366 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit | Stimwave Technologies Inc., Dba Stimq, LLC | 2017-08-04 |
| K152178 | StimQ Peripheral Nerve Stimulator (PNS) System | Stimq, LLC | 2016-03-11 |
| K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit | Bioness, Inc. | 2015-02-20 |
| K000852 | RENEW NEUROSTIMULATION SYSTEM | Advanced Neuromodulation Systems | 2001-01-19 |
| K000105 | MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), | Medtronic Vascular | 2000-04-12 |
| K982902 | PERIPHERAL NERVE STIMULATION | Medtronic Vascular | 1998-11-10 |
| K960631 | MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX | Medtronic Vascular | 1996-05-21 |
| K950425 | TECOTHANE 55D | Medtronic Vascular | 1995-04-19 |
| K925952 | MEDTRONIC MODEL 3990 PNS LEAD | Medtronic Vascular | 1993-08-20 |
| K920567 | MODELS 3987 AND 3988 RESUME LEAD FOR PNS | Medtronic Vascular | 1992-05-20 |
| K915540 | MODEL 3587A RESUME II LEAD | Medtronic Vascular | 1992-01-22 |
| K904409 | MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER | Medtronic Vascular | 1991-01-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00812537037752 | Nalu™ User Trial Kit | NALU MEDICAL, INC. | 2026-05-27 |
| 10812537030224 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 00812537030135 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 00812537030128 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 00812537030111 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 00812537030104 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 00812537030098 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 00812537030074 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 00812537030067 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 00812537030050 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 10812537030217 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 10812537030200 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 10812537030163 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 10812537030149 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 10812537030132 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 10812537030057 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 10812537030064 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 10812537030071 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 10812537030095 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 10812537030194 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 10812537030125 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 10812537030118 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 10812537030101 | Nalu Medical, Inc. | NALU MEDICAL, INC. | 2020-04-21 |
| 00643169953635 | N/A | MEDTRONIC, INC. | 2018-04-29 |
| 00643169986497 | NA | MEDTRONIC, INC. | 2018-03-18 |
| 00643169015371 | NA | MEDTRONIC, INC. | 2015-06-08 |
| 10681490077924 | NA | MEDTRONIC, INC. | 2015-06-08 |
| 00643169187948 | RESUME ® II | MEDTRONIC, INC. | 2014-09-23 |
| 00613994752178 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00613994354358 | RESUME II | MEDTRONIC, INC. | 2014-09-23 |