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FDA 510(k)

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

K-Number: K242841 · 2025-05-27

ApplicantABBOTT MEDICAL
Decision Date2025-05-27
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Related Devices (Code: GXI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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