510(k) K171366
- Device
- Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
- Applicant
- Stimwave Technologies Inc.,DBA StimQ LLC
- 510(k) number
- K171366
- Product code
- GZF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-08-04
- Date received
- 2017-05-09
- Regulation
- 882.5870
- Classification name
- Stimulator, Peripheral Nerve, Implanted (pain Relief)
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Elizabeth Greene
- Address
- 901 E Las Olas Blvd., Suite 201 Fort Lauderdale FL US 33301 33301
FDA Registration Numbers#
- 3016547665
- 2032521
- 3024996452
- 1627487
- 3008988055
- 3009595577
- 2135338
- 1928237
- 3004209178
- 2649622
- 3013023969
- 3012266672
- 3027669735
- 3009166798
- 3018094310
- 2246552
- 3022631685
- 2030624
- 2182207
- 3015425075
- 1422634
- 3010676138
- 3008255748
- 2183744
- 3019807891
- 3009183442
Source Documents#
Other 510(k) Records For Product Code GZF #
| 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 Kits and miscellaneous replacement kits | Boston Scientific Neuromodulation | 2019-03-29 |
| 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 |
Legacy Summary#
summary
FDA Review#
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