Freedom Spinal Cord Stimulator (SCS) System
FDA 510(k) K182720 · Stimwave Technologies Incorporated
510(k) numberK182720
Submission
- Device name
- Freedom Spinal Cord Stimulator (SCS) System
- Applicant
- Stimwave Technologies Incorporated
Pompano Beach, FL, US - Received
- September 28, 2018
- Decision date
- March 29, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GZB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System…GZB · Traditional | Boston Scientific Neuromodulation | 08/23/2024SE |
| K221376 | Nalu Neurostimulation SystemGZB · Special | Boston Scientific Neuromodulation | 06/10/2022SE |
| K203547 | Nalu Neurostimulation SystemGZB · Traditional | Boston Scientific Neuromodulation | 03/25/2021SE |
| K202274 | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit…GZB · Traditional | Boston Scientific Neuromodulation | 11/09/2020SE |
| K201618 | Nalu Neurostimulation SCS systemGZB · Special | Boston Scientific Neuromodulation | 07/15/2020SE |
| K191466 | SandShark Injectable Anchor (SIA) SystemGZB · Traditional | Stimwave Technologies, Inc. | 11/07/2019SE |
| K190960 | Nalu Lead Blank (50cm)GZB · Traditional | Boston Scientific Neuromodulation | 07/11/2019SE |
| K183047 | Nalu Neurostimulation SystemGZB · Traditional | Boston Scientific Neuromodulation | 03/22/2019SE |
| K180981 | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitGZB · Traditional | Stimwave Technologies Incorporated | 09/19/2018SE |
| K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading…GZB · Traditional | Stimwave Technologies Incorporated | 11/03/2017SE |
More from Stimwave Technologies Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K191466 | SandShark Injectable Anchor (SIA) SystemGZB · Traditional | 11/07/2019SE |
| K180981 | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitGZB · Traditional | 09/19/2018SE |
| K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading…GZB · Traditional | 11/03/2017SE |
| K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly…GZB · Traditional | 05/02/2017SE |
| K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly…GZB · Traditional | 12/16/2016SE |
| K160600 | Freedom Spinal Cord Stimulator SystemGZB · Traditional | 08/26/2016SE |
| K150517 | Freedom Spinal Cord Stimulator SystemGZB · Traditional | 06/05/2015SE |
| K141399 | Freedom Spinal Cord Stimulator (SCS) SystemGZB · Traditional | 10/10/2014SE |
Questions and answers
When was Freedom Spinal Cord Stimulator (SCS) System cleared by the FDA?
Freedom Spinal Cord Stimulator (SCS) System (K182720) received a 510(k) decision of Substantially Equivalent on March 29, 2019, 182 days after the submission was received.
What is the product code of K182720?
The FDA product code is GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5880.