GXZ — Electrode, Needle Class II
FDA product code GXZ covers "Electrode, Needle", a Class II medical device regulated under 21 CFR 882.1350. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GXZ
- Device Class
- Class II
- Regulation Number
- 882.1350
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241045 | technomed europe | Disposable Subdermal Needle Electrode, Corkscrew | December 11, 2024 |
| K232581 | suzhou haishen medical device associates co | Medical Disposable Sterile Needle Electrode | December 4, 2023 |
| K231691 | tedan surgical innovations | Phantom XL Insulated Dilators | June 29, 2023 |
| K200984 | rhythmlink international | Guardian Needle Electrode | May 27, 2020 |
| K192603 | spes medica | Spes Medica Subdermal Needle Electrodes | November 22, 2019 |
| K190801 | rhythmlink international | PressOn Electrode Headset | July 10, 2019 |
| K161566 | daehan medical systems co | DMS Disposable Subdermal Needle Electrodes | December 21, 2016 |
| K142470 | neuroinvent | E-Shield Multi-paried Subdermal Needle Electrodes | November 5, 2014 |
| K140200 | neuroinvent | E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES | July 18, 2014 |
| K130220 | rhythmlink international | MR CONDITIONAL PRESSON ELECTRODE | July 22, 2013 |
| K130136 | technomed europe | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUB | July 19, 2013 |
| K121347 | rhythmlink international | PRESSON ELECTRODE | July 12, 2012 |
| K103103 | persyst development | PRESSON ELECTRODE | December 8, 2011 |
| K110419 | stryker spine | AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS | July 28, 2011 |
| K100912 | kirwan surgical products | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULA | August 19, 2010 |
| K073229 | pioneer surgical technology | NERVE MONITORING CABLE | June 6, 2008 |
| K072276 | xian friendship electronics co | SUBDERMAL NEEDLE ELECTRODES | May 16, 2008 |
| K063729 | technomed europe | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 | August 21, 2007 |
| K071185 | ambu | MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE | May 30, 2007 |
| K062996 | axon systems | DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES | January 12, 2007 |