Cleared Special

K081729 - MODIFICATION TO GFX NERVE ABLATION SYSTEM

K081729 is an FDA 510(k) clearance for MODIFICATION TO GFX NERVE ABLATION SYSTEM, manufactured by Bioform Medical, Inc.. The device is a Class 2 Neurology device with product code GXD cleared through the Special 510(k) pathway after a 50-day FDA review.

K081729 · Bioform Medical, Inc. · Neurology device
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Aug 2008
Decision
50d
Days
Class 2
Risk

K081729 is an FDA 510(k) clearance for the MODIFICATION TO GFX NERVE ABLATION SYSTEM. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Bioform Medical, Inc. (Franksville, US). The FDA issued a Cleared decision on August 7, 2008 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4400 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bioform Medical, Inc. devices

FDA 510(k) Submission Details - K081729

510(k) Number K081729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2008
Decision Date August 07, 2008
Days to Decision 50 days
Submission Type Special
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
98d faster than avg
Panel avg: 148d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

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 32
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K081729.
NT 2000 LESIONING GENERATOR
K111576 · Neuro Therm, Inc. · Sep 2011
OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
K093185 · Diros Technology, Inc. · Jan 2010
COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
K082051 · Cosman Medical, Inc. · Oct 2008
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
K071482 · Synergetics, Inc. · Dec 2007
GFX NERVE ABLATION SYSTEM
K063753 · Aci, Inc. · Jun 2007
STOCKERT NEURO N50, MODEL12267
K070336 · Stockert GmbH · Jun 2007