GZB — Stimulator, Spinal-Cord, Implanted (Pain Relief) Class II
FDA product code GZB covers "Stimulator, Spinal-Cord, Implanted (Pain Relief)", a Class II medical device regulated under 21 CFR 882.5880. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GZB
- Device Class
- Class II
- Regulation Number
- 882.5880
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233801 | boston scientific neuromodulation | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation | August 23, 2024 |
| K221376 | boston scientific neuromodulation | Nalu Neurostimulation System | June 10, 2022 |
| K203547 | boston scientific neuromodulation | Nalu Neurostimulation System | March 25, 2021 |
| K202274 | boston scientific neuromodulation | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimula | November 9, 2020 |
| K201618 | boston scientific neuromodulation | Nalu Neurostimulation SCS system | July 15, 2020 |
| K191466 | stimwave technologies | SandShark Injectable Anchor (SIA) System | November 7, 2019 |
| K190960 | boston scientific neuromodulation | Nalu Lead Blank (50cm) | July 11, 2019 |
| K182720 | stimwave technologies incorporated | Freedom Spinal Cord Stimulator (SCS) System | March 29, 2019 |
| K183047 | boston scientific neuromodulation | Nalu Neurostimulation System | March 22, 2019 |
| K180981 | stimwave technologies incorporated | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit | September 19, 2018 |
| K172644 | stimwave technologies incorporated | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, | November 3, 2017 |
| K170141 | stimwave technologies incorporated | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna | May 2, 2017 |
| K162161 | stimwave technologies incorporated | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna | December 16, 2016 |
| K160600 | stimwave technologies incorporated | Freedom Spinal Cord Stimulator System | August 26, 2016 |
| K150924 | anchor innovation medical (a.i.m.) | A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device | July 27, 2015 |
| K150517 | stimwave technologies incorporated | Freedom Spinal Cord Stimulator System | June 5, 2015 |
| K141399 | stimwave technologies incorporated | FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM | October 10, 2014 |
| K140272 | st jude medical | SWIFT-LOCK ANCHOR | May 2, 2014 |
| K130545 | st jude medical | MULTI LEAD TRIAL CABLE | June 18, 2013 |
| K123299 | st. jude medical neuromodulation | MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS | January 18, 2013 |