Cleared Traditional

K242841 - Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)

K242841 is an FDA 510(k) clearance for Disposable RF Electrode (RFDE-5/RFDE-10..., manufactured by Abbott Medical. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 250-day FDA review.

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

FDA 510(k) Submission Details - K242841

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.

GXI Device Classification - Class 2, Special Controls

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 54
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
Intracept Intraosseous Nerve Ablation System
K222281 · Relievant Medsystems, Inc. · Oct 2022