FDA 510(k)

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

N.º K: K242841 · 2025-05-27

Fecha de decisión2025-05-27

Código de productoGXI

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-05-27 under 510(k) number K242841. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) is a medical device that received FDA 510(k) clearance on 2025-05-27. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K242841.

When did Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) receive FDA 510(k) clearance?

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) received FDA 510(k) clearance on 2025-05-27, under 510(k) number K242841.

Who is the listed applicant for Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) is GXI.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.