Ambu Neuroline Concentric Needle Electrode
FDA 510(k)Class II (US FDA 510(k))
by Ambu A/S
Identifiers
- 510(k) Number
- K071186 FDA 510(k)
- FDA Product Code
- IKT FDA 510(k)
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 Ambu Neuroline Concentric Needle Electrode is a concentric needle electrode designed for electromyography (EMG). It features a stainless steel cannula as the reference point and an inner conductor as the active measurement point, separated by insulation. The cannula is coated with a low-friction polymer to facilitate insertion and reduce patient discomfort during diagnostic procedures.
This device is supplied as a sterile, single-patient-use electrode, intended for use in physical medicine settings. It is classified as a Class II medical device under FDA regulations (890.1385) and has received a 510(k) clearance for substantial equivalence. Available in multiple sizes, it is regulated for diagnostic electromyographic assessments and must be stored according to manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What is the Ambu Neuroline Concentric Needle Electrode used for?
The Ambu Neuroline Concentric Needle Electrode is specifically designed for electromyography (EMG) procedures. EMG is a diagnostic test used to evaluate the health of muscles and the nerve cells that control them. The concentric design allows for precise needle placement, enabling accurate measurement of muscle response, which helps in diagnosing conditions like neuromuscular disorders, nerve compression, or muscle diseases.
How is the Ambu Neuroline Concentric Needle Electrode supplied, and is it reusable?
The Ambu Neuroline Concentric Needle Electrode is supplied as a sterile, single-patient-use device. This ensures safety and hygiene for each procedure, reducing the risk of cross-contamination. Single-use electrodes are also designed for convenience, as they eliminate the need for cleaning, sterilization, or reprocessing between patients.
What materials are used in the Ambu Neuroline Concentric Needle Electrode, and how does this affect patient comfort?
The electrode features a stainless steel cannula as the reference point and an inner conductor as the active measurement point, both separated by insulation. The cannula is coated with a low-friction polymer, which significantly reduces friction during insertion. This design minimizes patient discomfort, making the procedure more tolerable for patients undergoing EMG diagnostics.
Are there different sizes available for the Ambu Neuroline Concentric Needle Electrode?
Yes, the Ambu Neuroline Concentric Needle Electrode is available in multiple sizes. Different needle sizes cater to varying patient anatomies and clinical needs, allowing clinicians to select the most appropriate electrode for accurate and comfortable EMG assessments. The manufacturer provides guidelines to help determine the correct size based on the procedure requirements.
How should the Ambu Neuroline Concentric Needle Electrode be stored to maintain sterility and functionality?
To maintain sterility and functionality, the Ambu Neuroline Concentric Needle Electrode should be stored according to the manufacturer’s guidelines. Typically, this involves keeping the device in its original, sealed packaging until immediately before use. Storage should be in a clean, dry environment, protected from extreme temperatures, moisture, and direct sunlight. Proper storage ensures the electrode remains sterile and ready for accurate diagnostic use.
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: Modification To: Ambu Neuroline Concentric Needle Electrode (K071186 ..., Ambu® Neuroline™ Concentric - for EMG, Modification To: Ambu Neuroline Concentric Needle Electrode, Ambu® Neuroline Concentric
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071186 | Class II | Active |
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Manufacturer
- Manufacturer
- Ambu A/S
Sources (1)
- FDA 510(k) K071186 24 fields · synced Oct 1, 2026