Cleared Traditional

K201610 - IonicRF Generator (FDA 510(k) Clearance)

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

K201610 · Abbott Medical · Neurology device
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Oct 2020
Decision
128d
Days
Class 2
Risk

K201610 is an FDA 510(k) clearance for the IonicRF Generator. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Abbott Medical (Plymouth, US). The FDA issued a Cleared decision on October 21, 2020 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4400 - 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.

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Submission Details

510(k) Number K201610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2020
Decision Date October 21, 2020
Days to Decision 128 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 148d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXD Generator, Lesion, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4400
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 - GXD Generator, Lesion, Radiofrequency

All 36
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K201610.
GX1 Radiofrequency Generator Kit (RFG-X1-120V)
K251247 · Boston Scientific Neuromodulation Corporation · Aug 2025
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
K242057 · Avanos Medical, Inc. · Aug 2024
Racz Neurostat RF Generator
K232632 · Epimed International · May 2024
OneRF Ablation System
K231675 · Neuroone Medical Technologies Corp. · Dec 2023
APEX 6
K220122 · Rf Innovations, Inc. · Mar 2023
Abbott Medical Grounding Pad, model RF-DGP-IS
K203293 · Abbott Medical · Jan 2022