Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001) +5 more mo…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253581 FDA 510(k)
- FDA Product Code
- IKT FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.1385 FDA 510(k)
- Regulation Number
- 890.1385 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Disposable Concentric Needle Electrode is a diagnostic electromyograph device designed for percutaneous insertion to record biopotential signals. These single-use, concentric needle electrodes feature a central stimulating wire surrounded by a conductive outer shaft, enabling precise electrical signal capture during electromyography or nerve conduction studies.
These electrodes are supplied sterile and intended for single-use in clinical settings, including physical medicine. Available in six sizes—0.30x25mm (Red), 0.40x25mm (Yellow), 0.30x30mm (Pink), 0.45x37mm (Green), 0.45x50mm (Blue), and 0.60x75mm (Violet)—they are classified under product code IKT and comply with FDA 510(k) clearance (K253581) and MDD authorisations. Storage requires adherence to manufacturer guidelines for sterile packaging integrity.
Frequently asked questions
What clinical specialties are these disposable concentric needle electrodes primarily used in, and why are they designed this way?
These electrodes are primarily used in physical medicine, particularly for electromyography (EMG) and nerve conduction studies. Their design—with a central stimulating wire surrounded by a conductive outer shaft—allows for precise percutaneous insertion to capture biopotential signals accurately. This makes them ideal for diagnosing neuromuscular conditions, muscle dysfunctions, and nerve-related disorders in specialized physical medicine settings.
Are these electrodes reusable, or do they need to be discarded after a single use? What does that mean for clinical workflows?
These electrodes are intended for single-use only and are supplied sterile. This design ensures patient safety by eliminating cross-contamination risks between uses. Clinicians should follow standard single-use protocols, discarding them immediately after one procedure and opening a new sterile package for subsequent patients, which aligns with best practices for sterile medical devices.
What sizes are available, and how do I determine which one to use for a specific patient?
Six sizes are available: 0.30x25mm (Red), 0.40x25mm (Yellow), 0.30x30mm (Pink), 0.45x37mm (Green), 0.45x50mm (Blue), and 0.60x75mm (Violet). The first number indicates the outer diameter (in mm), while the second indicates the length. Selection depends on the patient’s anatomy, the depth of the target muscle or nerve, and the clinician’s preference for precision. For example, shorter lengths (e.g., 25mm) are typically used for superficial muscles, while longer lengths (e.g., 75mm) may be needed for deeper structures.
How should these electrodes be stored to maintain sterility and functionality?
These electrodes must be stored according to the manufacturer’s guidelines to preserve sterility and packaging integrity. They come pre-sterilized in sealed packaging, so storage should avoid exposure to moisture, extreme temperatures, or physical damage. Always check the packaging for signs of compromise before use, and adhere to expiration dates to ensure optimal performance and compliance with sterile medical device protocols.
What regulatory pathways have these electrodes undergone, and what does that mean for purchasing or using them?
These electrodes have undergone FDA 510(k) clearance (K253581) and comply with MDD (Medical Device Directive) authorizations, confirming they meet U.S. and EU regulatory standards for diagnostic electromyograph devices. This means they are classified as Class II devices under FDA regulations and are suitable for use in clinical settings where electromyography is performed. Purchasers should verify local regulatory compliance and ensure proper documentation is maintained.
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 Needle Electrode 0.30x25mm Red (TE/B50700-001 ..., K253581 FDA 510(k) - Disposable Concentric Needle Electrode ..., Disposable Concentric Needle Electrode 0.30x25mm Red… - FDA.report, Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001 ...
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 | K253581 | Class II | Active |
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Manufacturer
- Manufacturer
- Technomed Europe
Sources (2)
- FDA 510(k) K253581 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026