GXZ · Electrode, Needle
Neurology · 21 CFR 882.1350 · Class 2
Overview
| Product Code | GXZ |
|---|---|
| Device Name | Electrode, Needle |
| Regulation | 21 CFR 882.1350 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | Dec 11, 2024 | SESE |
| K232581 | Medical Disposable Sterile Needle Electrode | Suzhou Haishen Medical Device Associates Co., Ltd. | Dec 4, 2023 | SESE |
| K231691 | Phantom XL Insulated Dilators | TeDan Surgical Innovations, Inc. | Jun 29, 2023 | SESE |
| K200984 | Guardian Needle Electrode | Rhythmlink International, LLC | May 27, 2020 | SESE |
| K192603 | Spes Medica Subdermal Needle Electrodes | Spes Medica Srl | Nov 22, 2019 | SESE |
| K190801 | PressOn Electrode Headset | Rhythmlink International, LLC | Jul 10, 2019 | SESE |
| K161566 | DMS Disposable Subdermal Needle Electrodes | Daehan Medical Systems Co., Ltd. | Dec 21, 2016 | SESE |
| K142470 | E-Shield Multi-paried Subdermal Needle Electrodes | Neuroinvent, Inc. | Nov 5, 2014 | SESE |
| K140200 | E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES | Neuroinvent, Inc. | Jul 18, 2014 | SESE |
| K130220 | MR CONDITIONAL PRESSON ELECTRODE | Rhythmlink International, LLC | Jul 22, 2013 | SESE |
| K130136 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, | Technomed Europe | Jul 19, 2013 | SESE |
| K121347 | PRESSON ELECTRODE | Rhythmlink International, LLC | Jul 12, 2012 | SESE |
| K103103 | PRESSON ELECTRODE | Persyst Development Corp. | Dec 8, 2011 | SESE |
| K110419 | AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS | Stryker Spine | Jul 28, 2011 | SESE |
| K100912 | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE | Kirwan Surgical Products, Inc. | Aug 19, 2010 | SESE |
| K073229 | NERVE MONITORING CABLE | Pioneer Surgical Technology | Jun 6, 2008 | SESE |
| K072276 | SUBDERMAL NEEDLE ELECTRODES | Xian Friendship Electronics Co., Ltd. | May 16, 2008 | SESE |
| K063729 | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 | Technomed Europe | Aug 21, 2007 | SESE |
| K071185 | MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE | Ambu A/S | May 30, 2007 | SESE |
| K062996 | DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES | Axon Systems, Inc. | Jan 12, 2007 | SESE |
Top Applicants
- Rhythmlink International, LLC — 5 clearances
- Cadwell Laboratories, Inc. — 4 clearances
- Technomed Europe — 4 clearances
- Axon Systems, Inc. — 2 clearances
- Class A Ent. — 2 clearances
