FDA Product Code
FDA Product Code GZF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5870
510(k) Clearances — 25 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253877 | StimTrial Neuromodulation System | Bioventus, LLC | 2026-08-26 | Special | PDF ↗ |
| K243782 | StimTrial Neuromodulation System | Bioventus, LLC | 2025-07-16 | Traditional | PDF ↗ |
| K243678 | TalisMann Neuromodulation System | Bioventus, LLC | 2025-07-03 | Traditional | PDF ↗ |
| K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation | 2024-08-21 | Traditional | PDF ↗ |
| K233162 | Freedom Peripheral Nerve Stimulator (PNS) System | Curonix | 2024-06-20 | Traditional | PDF ↗ |
| K221303 | Neuspera Nuity System | Neuspera Medical, Inc. | 2023-04-11 | Traditional | PDF ↗ |
| K211965 | StimRouter Neuromodulation System | Bioness, Inc. | 2022-02-23 | Traditional | PDF ↗ |
| K202781 | Neuspera Neurostimulation System (NNS) | Neuspera Medical, Inc. | 2021-08-27 | Traditional | PDF ↗ |
| K200848 | Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit | Micron Medical Corporation | 2020-08-14 | Traditional | PDF ↗ |
| K200482 | StimRouter Neuromodulation System | Bioness, Inc. | 2020-03-27 | Special | PDF ↗ |
| K190047 | StimRouter Neuromodulation System | Bioness, Inc. | 2019-10-31 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| 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 | 2019-03-29 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K152178 | StimQ Peripheral Nerve Stimulator (PNS) System | Stimq, LLC | 2016-03-11 | Traditional | PDF ↗ |
| K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit | Bioness, Inc. | 2015-02-20 | Traditional | PDF ↗ |
| K000852 | RENEW NEUROSTIMULATION SYSTEM | Advanced Neuromodulation Systems | 2001-01-19 | Traditional | PDF ↗ |
| K000105 | MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), | Medtronic Vascular | 2000-04-12 | Traditional | PDF ↗ |
| K982902 | PERIPHERAL NERVE STIMULATION | Medtronic Vascular | 1998-11-10 | Traditional | PDF ↗ |
| K960631 | MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX | Medtronic Vascular | 1996-05-21 | Traditional | PDF ↗ |
| K950425 | TECOTHANE 55D | Medtronic Vascular | 1995-04-19 | Traditional | PDF ↗ |
| K925952 | MEDTRONIC MODEL 3990 PNS LEAD | Medtronic Vascular | 1993-08-20 | Traditional | PDF ↗ |
| K920567 | MODELS 3987 AND 3988 RESUME LEAD FOR PNS | Medtronic Vascular | 1992-05-20 | Traditional | PDF ↗ |
| K915540 | MODEL 3587A RESUME II LEAD | Medtronic Vascular | 1992-01-22 | Traditional | PDF ↗ |
| K904409 | MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER | Medtronic Vascular | 1991-01-30 | Traditional | PDF ↗ |
Product code GZF · Class II · Neurology. Data: openFDA.