MiniStim MS-IVB Peripheral Nerve Stimulator
FDA 510(k) K143095 · Halyard Health, Inc.
510(k) numberK143095
Submission
- Device name
- MiniStim MS-IVB Peripheral Nerve Stimulator
- Applicant
- Halyard Health, Inc.
Roswell, GA, US - Received
- October 28, 2014
- Decision date
- March 24, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| K110118 | Stimtrode Single Use Nerve StimulatorBXN · Special | Xavant Technology (Pty), Ltd. | 02/17/2011SE |
| 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 |
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| K162930 | Aero Chrome* Select Breathable Performance Surgical GownsFYA · Traditional | 04/21/2017SE |
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| K163236 | COOLIEF Cooled Radiofrequency KitGXI · Traditional | 12/16/2016SE |
| K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitBSO · Traditional | 09/30/2016SE |
| K160709 | HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam GlovesLZC · Abbreviated | 09/06/2016SE |
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Questions and answers
When was MiniStim MS-IVB Peripheral Nerve Stimulator cleared by the FDA?
MiniStim MS-IVB Peripheral Nerve Stimulator (K143095) received a 510(k) decision of Substantially Equivalent on March 24, 2015, 147 days after the submission was received.
What is the product code of K143095?
The FDA product code is BXN – Stimulator, Nerve, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 868.2775.