STIMTRODE SINGLE USE NERVE STIMULATOR
FDA 510(k) clearance K110118 · decided 2011-02-17
Clearance details
- K-number
- K110118
- Device name
- STIMTRODE SINGLE USE NERVE STIMULATOR
- Applicant
- Xavant Technology (Pty), Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-01-18
- Decision date
- 2011-02-17
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- BXN
- Device class
- 2
- Regulation number
- 868.2775
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Pretoria, Gauteng, ZA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STIMPOD NMS450 Nerve Stimulator (K213049) | Xavant Technology (Pty), Ltd. | 2022-10-16 |
| MultiStim ECO (K162086) | PAJUNK GmbH Medizintechnologie | 2017-01-06 |
| SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator (K153045) | Easy Med Instrument Co., Ltd. | 2016-05-13 |
| MiniStim MS-IVB Peripheral Nerve Stimulator (K143095) | Halyard Health, Inc. | 2015-03-24 |
| STIMPOD ST2-3010 NERVE STIMULATOR (K140853) | Xavant Technology (Pty), Ltd. | 2014-11-06 |
| EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN (K121743) | Sunmed, LLC | 2013-03-28 |
| MYOGUIDE SYSTEM MODEL 8008 (K111985) | Intronix Technologies Corp. | 2011-12-30 |
| STIMPOD NMS450 NERVE STIMULATOR (K102084) | Xavant Technology (Pty), Ltd. | 2010-12-16 |
| STIMPOD MODEL NMS-400 NERVE STIMULATOR (K093591) | Xavant Technology (Pty), Ltd. | 2009-12-03 |
| ASCEND (K091155) | Neurometrix, Inc. | 2009-09-03 |
| XPOD/XMAP NERVE STIMULATOR (K072092) | Xavant Technology (Pty), Ltd. | 2007-11-15 |
| MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 (K070134) | Stockert GmbH | 2007-03-22 |
Recalls involving this device
No recalls on record reference this clearance.