Stimtrode Single Use Nerve Stimulator
FDA 510(k) K110118 · Xavant Technology (Pty), Ltd.
510(k) numberK110118
Submission
- Device name
- Stimtrode Single Use Nerve Stimulator
- Applicant
- Xavant Technology (Pty), Ltd.
Pretoria, Gauteng, ZA - Received
- January 18, 2011
- Decision date
- February 17, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BXN – Stimulator, Nerve, Battery-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2775
- Specialty
- Anesthesiology
Other 510(k)s with product code BXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213049 | STIMPOD NMS450 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 10/16/2022SE |
| K162086 | MultiStim ECOBXN · Traditional | PAJUNK GmbH Medizintechnologie | 01/06/2017SE |
| K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorBXN · Special | Easy Med Instrument Co., Ltd. | 05/13/2016SE |
| K143095 | MiniStim MS-IVB Peripheral Nerve StimulatorBXN · Traditional | Halyard Health, Inc. | 03/24/2015SE |
| K140853 | Stimpod ST2-3010 Nerve StimulatorBXN · Special | Xavant Technology (Pty), Ltd. | 11/06/2014SE |
| K121743 | Easymed Peripheral Nerve Stimulator-SunstinBXN · Traditional | Sunmed, LLC | 03/28/2013SE |
| K111985 | Myoguide System Model 8008BXN · Traditional | Intronix Technologies Corp. | 12/30/2011SE |
| K102084 | Stimpod NMS450 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 12/16/2010SE |
| K093591 | Stimpod Model NMS-400 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 12/03/2009SE |
| K091155 | AscendBXN · Traditional | Neurometrix, Inc. | 09/03/2009SE |
More from Neurometrix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213049 | STIMPOD NMS450 Nerve StimulatorBXN · Traditional | 10/16/2022SE |
| K161091 | STIMPOD NMS460 Nerve StimulatorGZJ · Traditional | 01/18/2017SE |
| K140853 | Stimpod ST2-3010 Nerve StimulatorBXN · Special | 11/06/2014SE |
| K102084 | Stimpod NMS450 Nerve StimulatorBXN · Traditional | 12/16/2010SE |
| K093591 | Stimpod Model NMS-400 Nerve StimulatorBXN · Traditional | 12/03/2009SE |
| K072092 | Xpod/Xmap Nerve StimulatorBXN · Traditional | 11/15/2007SE |
Questions and answers
When was Stimtrode Single Use Nerve Stimulator cleared by the FDA?
Stimtrode Single Use Nerve Stimulator (K110118) received a 510(k) decision of Substantially Equivalent on February 17, 2011, 30 days after the submission was received.
What is the product code of K110118?
The FDA product code is BXN – Stimulator, Nerve, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 868.2775.