Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Pro…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050325 FDA 510(k)
- FDA Product Code
- GXZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1350 FDA 510(k)
- Regulation Number
- 882.1350 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a disposable electrode designed for electrical nerve stimulation and electromyography (EMG) signal acquisition. The probes are available in three configurations: concentric, bipolar, and monopolar, each serving as passive electrodes for precise stimulation and recording during neurological assessments.
The probes are intended for single-use and are supplied sterile. They are classified as Class II medical devices under FDA regulations and comply with the Medical Device Directive (MDD). Each probe type features distinct electrode arrangements, with the monopolar probe including a 2 mm tip-free insulation for targeted stimulation. Authorisations include FDA 510K clearance and MDD compliance, ensuring adherence to regulatory standards for neurological applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Disposable Concentric Probe, Disposable Bipolar Probe, Disposable ..., Our products - Technomed, PDF PRODUCT CATALOGUE - technomedmedical.com, Disposable Concentric Probe, Disposable Bipolar Probe, Disposable ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K050325 | Class II | Active |
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Manufacturer
- Manufacturer
- Technomed Europe
Sources (2)
- FDA 510(k) K050325 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026