Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1350](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1350) → GXZ — Electrode, Needle # GXZ · Electrode, Needle _Neurology · 21 CFR 882.1350 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ ## Overview - **Product Code:** GXZ - **Device Name:** Electrode, Needle - **Regulation:** [21 CFR 882.1350](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1350) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **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](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K241045.md) | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | Dec 11, 2024 | SESE | | [K232581](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K232581.md) | Medical Disposable Sterile Needle Electrode | Suzhou Haishen Medical Device Associates Co., Ltd. | Dec 4, 2023 | SESE | | [K231691](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K231691.md) | Phantom XL Insulated Dilators | TeDan Surgical Innovations, Inc. | Jun 29, 2023 | SESE | | [K200984](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K200984.md) | Guardian Needle Electrode | Rhythmlink International, LLC | May 27, 2020 | SESE | | [K192603](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K192603.md) | Spes Medica Subdermal Needle Electrodes | Spes Medica Srl | Nov 22, 2019 | SESE | | [K190801](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K190801.md) | PressOn Electrode Headset | Rhythmlink International, LLC | Jul 10, 2019 | SESE | | [K161566](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K161566.md) | DMS Disposable Subdermal Needle Electrodes | Daehan Medical Systems Co., Ltd. | Dec 21, 2016 | SESE | | [K142470](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K142470.md) | E-Shield Multi-paried Subdermal Needle Electrodes | Neuroinvent, Inc. | Nov 5, 2014 | SESE | | [K140200](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K140200.md) | E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES | Neuroinvent, Inc. | Jul 18, 2014 | SESE | | [K130220](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K130220.md) | MR CONDITIONAL PRESSON ELECTRODE | Rhythmlink International, LLC | Jul 22, 2013 | SESE | | [K130136](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K130136.md) | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, | Technomed Europe | Jul 19, 2013 | SESE | | [K121347](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K121347.md) | PRESSON ELECTRODE | Rhythmlink International, LLC | Jul 12, 2012 | SESE | | [K103103](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K103103.md) | PRESSON ELECTRODE | Persyst Development Corp. | Dec 8, 2011 | SESE | | [K110419](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K110419.md) | AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS | Stryker Spine | Jul 28, 2011 | SESE | | [K100912](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K100912.md) | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE | Kirwan Surgical Products, Inc. | Aug 19, 2010 | SESE | | [K073229](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K073229.md) | NERVE MONITORING CABLE | Pioneer Surgical Technology | Jun 6, 2008 | SESE | | [K072276](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K072276.md) | SUBDERMAL NEEDLE ELECTRODES | Xian Friendship Electronics Co., Ltd. | May 16, 2008 | SESE | | [K063729](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K063729.md) | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 | Technomed Europe | Aug 21, 2007 | SESE | | [K071185](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K071185.md) | MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE | Ambu A/S | May 30, 2007 | SESE | | [K062996](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K062996.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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