BXN — Stimulator, Nerve, Battery-Powered Class II
FDA product code BXN covers "Stimulator, Nerve, Battery-Powered", a Class II medical device regulated under 21 CFR 868.2775. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BXN
- Device Class
- Class II
- Regulation Number
- 868.2775
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K213049 | xavant technology (pty) | STIMPOD NMS450 Nerve Stimulator | October 16, 2022 |
| K162086 | pajunk gmbh medizintechnologie | MultiStim ECO | January 6, 2017 |
| K153045 | easy med instrument co | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator | May 13, 2016 |
| K143095 | halyard health | MiniStim MS-IVB Peripheral Nerve Stimulator | March 24, 2015 |
| K140853 | xavant technology (pty) | STIMPOD ST2-3010 NERVE STIMULATOR | November 6, 2014 |
| K121743 | sunmed | EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN | March 28, 2013 |
| K111985 | intronix technologies | MYOGUIDE SYSTEM MODEL 8008 | December 30, 2011 |
| K110118 | xavant technology (pty) | STIMTRODE SINGLE USE NERVE STIMULATOR | February 17, 2011 |
| K102084 | xavant technology (pty) | STIMPOD NMS450 NERVE STIMULATOR | December 16, 2010 |
| K093591 | xavant technology (pty) | STIMPOD MODEL NMS-400 NERVE STIMULATOR | December 3, 2009 |
| K091155 | neurometrix | ASCEND | September 3, 2009 |
| K072092 | xavant technology (pty) | XPOD/XMAP NERVE STIMULATOR | November 15, 2007 |
| K070134 | stockert | MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 | March 22, 2007 |
| K062478 | medtronic | CLAVIS | February 8, 2007 |
| K061983 | stockert | STIMUPLEX PEN | November 21, 2006 |
| K061172 | pajunk gmbh medizintechnologie | PAJUNK MULTISTIM SENSOR NERVE STIMULATORS | October 17, 2006 |
| K052313 | stockert | STIMUPLEX HNS-12, MODEL 4892098 | November 17, 2005 |
| K021033 | b.braun medical | STIMUPLEX-DIG-RC NERVE STIMULATOR | March 21, 2003 |
| K011308 | pajunk | MULTISTIM | November 29, 2001 |
| K990323 | te me na s.a.r.l | TE ME NA POLYSTIM NERVE STIMILATOR | September 28, 2001 |