GZB · Stimulator, Spinal-Cord, Implanted (Pain Relief)
Neurology · 21 CFR 882.5880 · Class 2
Overview
| Product Code | GZB |
|---|---|
| Device Name | Stimulator, Spinal-Cord, Implanted (Pain Relief) |
| Regulation | 21 CFR 882.5880 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 139)
Showing 20 most recent of 139 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation | Aug 23, 2024 | SESE |
| K221376 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | Jun 10, 2022 | SESE |
| K203547 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | Mar 25, 2021 | SESE |
| 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 | Nov 9, 2020 | SESE |
| K201618 | Nalu Neurostimulation SCS system | Boston Scientific Neuromodulation | Jul 15, 2020 | SESE |
| K191466 | SandShark Injectable Anchor (SIA) System | Stimwave Technologies, Inc. | Nov 7, 2019 | SESE |
| K190960 | Nalu Lead Blank (50cm) | Boston Scientific Neuromodulation | Jul 11, 2019 | SESE |
| K182720 | Freedom Spinal Cord Stimulator (SCS) System | Stimwave Technologies Incorporated | Mar 29, 2019 | SESE |
| K183047 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | Mar 22, 2019 | SESE |
| K180981 | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit | Stimwave Technologies Incorporated | Sep 19, 2018 | SESE |
| K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base | Stimwave Technologies Incorporated | Nov 3, 2017 | SESE |
| K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | Stimwave Technologies Incorporated | May 2, 2017 | SESE |
| K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | Stimwave Technologies Incorporated | Dec 16, 2016 | SESE |
| K160600 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | Aug 26, 2016 | SESE |
| 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.) | Jul 27, 2015 | SESE |
| K150517 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | Jun 5, 2015 | SESE |
| K141399 | FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM | Stimwave Technologies Incorporated | Oct 10, 2014 | SESE |
| K140272 | SWIFT-LOCK ANCHOR | St Jude Medical | May 2, 2014 | SESE |
| K130545 | MULTI LEAD TRIAL CABLE | St Jude Medical | Jun 18, 2013 | SESE |
| K123299 | MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS | St. Jude Medical Neuromodulation | Jan 18, 2013 | SESE |
Top Applicants
- Medtronic Vascular — 56 clearances
- Advanced Neuromodulation Systems — 24 clearances
- Neuromed, Inc. — 15 clearances
- Stimwave Technologies Incorporated — 8 clearances
- Boston Scientific Neuromodulation — 7 clearances
