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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 a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-05-27 under approval 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. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K242841.

When was Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) approved by the FDA?

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

What company makes Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)?

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) is manufactured by ABBOTT MEDICAL.

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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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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