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Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242841

by Abbott Medical

Identifiers

510(k) Number
K242841 FDA 510(k)
FDA Product Code
GXI FDA 510(k)
Models / Variants
RFDE-5 FDA 510(k)
RFDE-10 FDA 510(k)
RFDE-15 FDA 510(k)
RFDE-20 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4725 FDA 510(k)
Regulation Number
882.4725 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) is a Probe, Radiofrequency Lesion, designed for percutaneous radiofrequency ablation procedures. It delivers controlled radiofrequency energy to create targeted tissue lesions, primarily used in neurological applications to interrupt pain pathways by disrupting nerve function. The device is intended for single-use and is engineered to interface with radiofrequency generators for precise lesion formation during interventional procedures.

These electrodes are supplied sterile and disposable, available in four lengths (5 cm, 10 cm, 15 cm, and 20 cm) to accommodate varying clinical requirements. They are classified as Class II devices under FDA regulations and have received FDA 510(k) clearance as substantially equivalent to predicate devices. The electrodes are intended for use in MRI-safe environments, adhering to regulatory standards for radiofrequency ablation tools in neurology. Storage and handling follow standard sterile medical device protocols to ensure integrity before use.

Frequently asked questions

What is the Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) used for?

This device is designed for percutaneous radiofrequency ablation procedures in neurology. It delivers controlled radiofrequency energy to create targeted tissue lesions, primarily used to interrupt pain pathways by disrupting nerve function. This is particularly useful in clinical settings where precise lesion formation is required for neurological interventions.

How is the Disposable RF Electrode supplied and what are its key features?

The electrodes are supplied sterile and disposable, ensuring single-use and minimizing infection risks. They come in four distinct lengths—5 cm, 10 cm, 15 cm, and 20 cm—to accommodate varying clinical needs. Each electrode is engineered to interface with radiofrequency generators, enabling precise lesion formation during interventional procedures. The design adheres to MRI-safe standards, making it suitable for use in MRI environments.

Are these electrodes reusable or intended for single-use?

The Disposable RF Electrode is explicitly designed for single-use only. This design choice ensures sterility and safety, reducing the risk of cross-contamination between patients. Single-use devices also eliminate the need for reprocessing, simplifying workflows and ensuring consistent performance.

What storage and handling guidelines should be followed for these electrodes?

The electrodes must be stored according to standard sterile medical device protocols to maintain their integrity before use. This includes keeping them in their original packaging, in a clean and dry environment, and away from direct sunlight or extreme temperatures. Proper storage ensures the device remains sterile and functional until use, adhering to regulatory requirements for medical devices.

What regulatory approvals apply to the Disposable RF Electrode?

The Disposable RF Electrode has received FDA 510(k) clearance, demonstrating it is substantially equivalent to predicate devices. It is classified as a Class II device under FDA regulations, indicating it undergoes rigorous review to ensure safety and effectiveness. The device is also intended for use in MRI-safe environments, adhering to regulatory standards for radiofrequency ablation tools in neurology.

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: Abbott NeuroTherm Radiofrequency Electrodes - Disposable Electrode, 10 ..., Abbott NeuroTherm Radiofrequency Electrodes - Disposable Electrode, 10 ..., Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) (K242841 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Abbott Medical

Sources (1)

  • FDA 510(k) K242841 24 fields · synced Oct 1, 2026