BXN · Stimulator, Nerve, Battery-Powered
Anesthesiology · 21 CFR 868.2775 · Class 2
Overview
| Product Code | BXN |
|---|---|
| Device Name | Stimulator, Nerve, Battery-Powered |
| Regulation | 21 CFR 868.2775 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 63)
Showing 20 most recent of 63 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213049 | STIMPOD NMS450 Nerve Stimulator | Xavant Technology (Pty), Ltd. | Oct 16, 2022 | SESE |
| K162086 | MultiStim ECO | PAJUNK GmbH Medizintechnologie | Jan 6, 2017 | SESE |
| K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator | Easy Med Instrument Co., Ltd. | May 13, 2016 | SESE |
| K143095 | MiniStim MS-IVB Peripheral Nerve Stimulator | Halyard Health, Inc. | Mar 24, 2015 | SESE |
| K140853 | STIMPOD ST2-3010 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | Nov 6, 2014 | SESE |
| K121743 | EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN | Sunmed, LLC | Mar 28, 2013 | SESE |
| K111985 | MYOGUIDE SYSTEM MODEL 8008 | Intronix Technologies Corp. | Dec 30, 2011 | SESE |
| K110118 | STIMTRODE SINGLE USE NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | Feb 17, 2011 | SESE |
| K102084 | STIMPOD NMS450 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | Dec 16, 2010 | SESE |
| K093591 | STIMPOD MODEL NMS-400 NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | Dec 3, 2009 | SESE |
| K091155 | ASCEND | Neurometrix, Inc. | Sep 3, 2009 | SESE |
| K072092 | XPOD/XMAP NERVE STIMULATOR | Xavant Technology (Pty), Ltd. | Nov 15, 2007 | SESE |
| K070134 | MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 | Stockert GmbH | Mar 22, 2007 | SESE |
| K062478 | CLAVIS | Medtronic A/S | Feb 8, 2007 | SESE |
| K061983 | STIMUPLEX PEN | Stockert GmbH | Nov 21, 2006 | SESE |
| K061172 | PAJUNK MULTISTIM SENSOR NERVE STIMULATORS | PAJUNK GmbH Medizintechnologie | Oct 17, 2006 | SESE |
| K052313 | STIMUPLEX HNS-12, MODEL 4892098 | Stockert GmbH | Nov 17, 2005 | SESE |
| K021033 | STIMUPLEX-DIG-RC NERVE STIMULATOR | B.Braun Medical, Inc. | Mar 21, 2003 | SESE |
| K011308 | MULTISTIM | Pajunk GmbH | Nov 29, 2001 | SESE |
| K990323 | TE ME NA POLYSTIM NERVE STIMILATOR | Te ME NA S.A.R.L. | Sep 28, 2001 | SESE |
Top Applicants
- Biometer Intl. A/S — 6 clearances
- Xavant Technology (Pty), Ltd. — 6 clearances
- Stockert GmbH — 4 clearances
- Life-Tech Intl., Inc. — 3 clearances
- Regional Master Corp. — 3 clearances
