Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
FDA 510(k) K180981 · Stimwave Technologies Incorporated
510(k) numberK180981
Submission
- Device name
- Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
- Applicant
- Stimwave Technologies Incorporated
Pompano Beach, FL, US - Received
- April 13, 2018
- Decision date
- September 19, 2018
- 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 |
| K182720 | Freedom Spinal Cord Stimulator (SCS) SystemGZB · Traditional | Stimwave Technologies Incorporated | 03/29/2019SE |
| K183047 | Nalu Neurostimulation SystemGZB · Traditional | Boston Scientific Neuromodulation | 03/22/2019SE |
| 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 |
| K182720 | Freedom Spinal Cord Stimulator (SCS) SystemGZB · Traditional | 03/29/2019SE |
| 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 Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit cleared by the FDA?
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit (K180981) received a 510(k) decision of Substantially Equivalent on September 19, 2018, 159 days after the submission was received.
What is the product code of K180981?
The FDA product code is GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5880.