Cleared Traditional

K242841 - Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242841 · Abbott Medical · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
250d
Days
Class 2
Risk

K242841 is an FDA 510(k) clearance for the Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20). Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Abbott Medical (Plano, US). The FDA issued a Cleared decision on May 27, 2025 after a review of 250 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4725 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Medical devices

Submission Details

510(k) Number K242841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 148d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXI Probe, Radiofrequency Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXI Probe, Radiofrequency Lesion

All 65
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K242841.
Disposable Radiofrequency Cannula
K253907 · Abbott Medical · Apr 2026
STAR RF Ablation System
K251802 · Merit Medical Systems, Inc. · Feb 2026
OneRF Trigeminal Nerve Radiofrequency Probes
K251243 · Neuroone Medical Technologies Corp. · Aug 2025
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)
K250213 · Stryker Instruments · May 2025
RF Cannula
K241367 · Shanghai Samedical & Plastic Instruments Co., Ltd. · Jan 2025