Cleared Traditional

K063753 - GFX NERVE ABLATION SYSTEM

K063753 is an FDA 510(k) clearance for GFX NERVE ABLATION SYSTEM, manufactured by Aci, Inc.. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K063753 · Aci, Inc. · Neurology device
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Jun 2007
Decision
183d
Days
Class 2
Risk

K063753 is an FDA 510(k) clearance for the GFX NERVE ABLATION SYSTEM. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Aci, Inc. (Lakewood, US). The FDA issued a Cleared decision on June 20, 2007 after a review of 183 days - an extended review cycle.

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.

View all Aci, Inc. devices

FDA 510(k) Submission Details - K063753

510(k) Number K063753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2006
Decision Date June 20, 2007
Days to Decision 183 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 148d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GXD Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K063753.
Polaris RF Ablation System
K181864 · Baylis Medical Company, Inc. · Jan 2019
MultiGen™ 2 RF Generator System
K170242 · Stryker Corporation · May 2017
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
K071482 · Synergetics, Inc. · Dec 2007
STRYKER INTRADISCAL RF GENERATOR
K063489 · Synergetics, Inc. · May 2007
STRYKER INTERVENTIONAL PAIN RF GENERATOR
K032601 · Valley Forge Scientific Corp. · Apr 2004
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
K020354 · Baylis Medical Co., Inc. · May 2002