Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Regulation 882.5870
1510(k)s in 12 months (25 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in GZF
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 8 | 0 |
| Stimwave Technologies Inc | 0 | 6 |
| Bioness, Inc. | 4 | 0 |
| Bioventus, LLC | 3 | 0 |
| Boston Scientific Neuromodulation | 2 | 0 |
| Nalu Medical, Inc. | 1 | 1 |
| Neuspera Medical, Inc. | 2 | 0 |
| Advanced Neuromodulation Systems | 1 | 0 |
| Curonix | 1 | 0 |
| Micron Medical Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 2026 | K253877 | StimTrial Neuromodulation System Bioventus, LLC | GZF |
| Jul 16, 2025 | K243782 | StimTrial Neuromodulation System Bioventus, LLC | GZF |
| Jul 3, 2025 | K243678 | TalisMann Neuromodulation System Bioventus, LLC | GZF |
| Aug 21, 2024 | K232415 | Nalu Neurostimulation System for Peripheral Nerve Stimulation Boston Scientific Neuromodulation | GZF |
| Jun 20, 2024 | K233162 | Freedom Peripheral Nerve Stimulator (PNS) System Curonix | GZF |
| Apr 11, 2023 | K221303 | Neuspera Nuity System Neuspera Medical, Inc. | GZF |
| Feb 23, 2022 | K211965 | StimRouter Neuromodulation System Bioness, Inc. | GZF |
| Aug 27, 2021 | K202781 | Neuspera Neurostimulation System (NNS) Neuspera Medical, Inc. | GZF |
| Aug 14, 2020 | K200848 | Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit Micron Medical Corporation | GZF |
| Mar 27, 2020 | K200482 | StimRouter Neuromodulation System Bioness, Inc. | GZF |
| Oct 31, 2019 | K190047 | StimRouter Neuromodulation System Bioness, Inc. | GZF |
| Sep 6, 2019 | K191435 | IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 Nalu Medical, Inc. | GZF |
| Mar 29, 2019 | K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8 Boston Scientific Neuromodulation | GZF |
| Aug 4, 2017 | K171366 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit Stimwave Technologies Inc., Dba Stimq, LLC | GZF |
| Mar 11, 2016 | K152178 | StimQ Peripheral Nerve Stimulator (PNS) System Stimq, LLC | GZF |
| Feb 20, 2015 | K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit Bioness, Inc. | GZF |
| Jan 19, 2001 | K000852 | RENEW NEUROSTIMULATION SYSTEM Advanced Neuromodulation Systems | GZF |
| Apr 12, 2000 | K000105 | MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), Medtronic Vascular | GZF |
| Nov 10, 1998 | K982902 | PERIPHERAL NERVE STIMULATION Medtronic Vascular | GZF |
| May 21, 1996 | K960631 | MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX Medtronic Vascular | GZF |
| Apr 19, 1995 | K950425 | TECOTHANE 55D Medtronic Vascular | GZF |
| Aug 20, 1993 | K925952 | MEDTRONIC MODEL 3990 PNS LEAD Medtronic Vascular | GZF |
| May 20, 1992 | K920567 | MODELS 3987 AND 3988 RESUME LEAD FOR PNS Medtronic Vascular | GZF |
| Jan 22, 1992 | K915540 | MODEL 3587A RESUME II LEAD Medtronic Vascular | GZF |
| Jan 30, 1991 | K904409 | MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER Medtronic Vascular | GZF |
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