Cleared Traditional

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

K242841 · Abbott Medical · Neurology
May 2025
Decision
250d
Days
Class 2
Risk

About This 510(k) Submission

K242841 is an FDA 510(k) clearance for the Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20), a Probe, Radiofrequency Lesion (Class II — Special Controls, product code GXI), submitted by Abbott Medical (Plano, US). The FDA issued a Cleared decision on May 27, 2025, 250 days after receiving the submission on September 19, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4725.

Submission Details

510(k) Number K242841 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2024
Decision Date May 27, 2025
Days to Decision 250 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXI — Probe, Radiofrequency Lesion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4725

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