510(k) K162161
- Device
- Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit And Charger Kit
- Applicant
- Stimwave Technologies Incorporated
- 510(k) number
- K162161
- Product code
- GZB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-12-16
- Date received
- 2016-08-02
- Regulation
- 882.5880
- Classification name
- Stimulator, Spinal-cord, 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
- 3004593495
- 2032521
- 1627487
- 3007882731
- 2031093
- 3005160949
- 3008988055
- 2135338
- 2183787
- 1928237
- 1035166
- 3004209178
- 2024311
- 2649622
- 3013023969
- 3015924373
- 3009166798
- 3018094310
- 2246552
- 3022631685
- 2030624
- 2182207
- 3015425075
- 1422634
- 3010676138
- 3010531069
- 3006705815
- 3008255748
- 2124215
- 2183744
- 3019807891
- 3006630150
- 3009183442
Source Documents#
Other 510(k) Records For Product Code GZB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation | 2024-08-23 |
| K221376 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2022-06-10 |
| K203547 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2021-03-25 |
| K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits | Boston Scientific Neuromodulation | 2020-11-09 |
| K201618 | Nalu Neurostimulation SCS system | Boston Scientific Neuromodulation | 2020-07-15 |
| K191466 | SandShark Injectable Anchor (SIA) System | Stimwave Technologies, Inc. | 2019-11-07 |
| K190960 | Nalu Lead Blank (50cm) | Boston Scientific Neuromodulation | 2019-07-11 |
| K182720 | Freedom Spinal Cord Stimulator (SCS) System | Stimwave Technologies Incorporated | 2019-03-29 |
| K183047 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | 2019-03-22 |
| K180981 | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit | Stimwave Technologies Incorporated | 2018-09-19 |
| K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base | Stimwave Technologies Incorporated | 2017-11-03 |
| K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | Stimwave Technologies Incorporated | 2017-05-02 |
| K160600 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2016-08-26 |
| K150924 | A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device | Anchor Innovation Medical (A.I.M.) | 2015-07-27 |
| K150517 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2015-06-05 |
Legacy Summary#
summary
FDA Review#
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