Product Code: GXD FDA class 2 21 CFR 882.4400

Generator, Lesion, Radiofrequency

Neurology

The Radiofrequency Lesion Generator is a neurosurgical device used to create controlled thermal lesions in neural tissue, typically for pain management or the treatment of movement disorders by interrupting aberrant nerve pathways. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. The product code is GXD under regulation 21 CFR 882.4400 in the Neurology specialty. It is eligible for third-party review under the 510(k) program.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GXD
Device Class: FDA class 2
Regulation Number: 882.4400
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 37 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251247	GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)	Aug 07, 2025	Substantially Equivalent	Boston Scientific Neuromodulation Corporation
K242057	COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)	Aug 14, 2024	Substantially Equivalent	Avanos Medical, Inc.
K232632	Racz Neurostat RF Generator	May 24, 2024	Substantially Equivalent	Epimed International
K231675	OneRF Ablation System	Dec 06, 2023	Substantially Equivalent	Neuroone Medical Technologies Corp.
K220122	APEX 6	Mar 15, 2023	Substantially Equivalent	Rf Innovations, Inc.
K203293	Abbott Medical Grounding Pad, model RF-DGP-IS	Jan 21, 2022	Substantially Equivalent	ABBOTT MEDICAL
K201610	IonicRF Generator	Oct 21, 2020	Substantially Equivalent	ABBOTT MEDICAL
K192491	Coolief Radiofrequency Generator (CRG) System	Feb 21, 2020	Substantially Equivalent	Avanos Medical, Inc.
K181864	Polaris RF Ablation System	Jan 02, 2019	Substantially Equivalent	Baylis Medical Company, Inc.
K171143	Relievant Medsystems RF Generator	Aug 18, 2017	Substantially Equivalent	Relievant Medsystems
K170242	MultiGen 2 RF Generator System	May 25, 2017	Substantially Equivalent	Stryker Corporation
K101592	ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM	Oct 06, 2011	Substantially Equivalent	Cheng Medical, Corporation
K111576	NT 2000 LESIONING GENERATOR	Sep 20, 2011	Substantially Equivalent	Neuro Therm, Inc.
K093185	OWL UNIVERSAL RF SYSTEM URF-3AP (ML)	Jan 22, 2010	Substantially Equivalent	Diros Technology, Inc.
K082051	COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4	Oct 16, 2008	Substantially Equivalent	Cosman Medical, Inc.
K081729	MODIFICATION TO GFX NERVE ABLATION SYSTEM	Aug 07, 2008	Substantially Equivalent	Bioform Medical, Inc.
K071482	STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000	Dec 20, 2007	Substantially Equivalent	Synergetics, Inc.
K063753	GFX NERVE ABLATION SYSTEM	Jun 20, 2007	Substantially Equivalent	Aci, Inc.
K070336	STOCKERT NEURO N50, MODEL12267	Jun 14, 2007	Substantially Equivalent	Stockert GmbH
K063489	STRYKER INTRADISCAL RF GENERATOR	May 23, 2007	Substantially Equivalent	Synergetics, Inc.
K062758	OWL URF-3AP	Sep 27, 2006	Substantially Equivalent	Diros Technology, Inc.
K052878	NT-1000	Jan 23, 2006	Substantially Equivalent	Neuro Therm, Inc.
K040565	PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE	Jul 22, 2004	Substantially Equivalent	Physician Industries, Inc.
K032601	STRYKER INTERVENTIONAL PAIN RF GENERATOR	Apr 01, 2004	Substantially Equivalent	Valley Forge Scientific Corp.
K021869	OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP	Jul 01, 2002	Substantially Equivalent	Diros Technology, Inc.
K020354	BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)	May 03, 2002	Substantially Equivalent	Baylis Medical Co., Inc.
K010202	OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES	Oct 31, 2001	Substantially Equivalent	Leslie W. Organ
K002565	BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)	May 03, 2001	Substantially Equivalent	Baylis Medical Co., Inc.
K010969	NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES	Apr 20, 2001	Substantially Equivalent	Stryker Instruments
K983214	RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES	Mar 27, 2000	Unknown	Rita Medical Systems
K982489	RFG-3C PLUS	Oct 05, 1998	Substantially Equivalent	Radionics, Inc.
K965182	RFG-3CF	Mar 12, 1997	Substantially Equivalent	Radionics, Inc.
K963577	RADIONICS SLUIJTER-MEHTA CANNULA	Nov 21, 1996	Substantially Equivalent	Radionics, Inc.
K941823	LEKSELL NEURO GENERATOR AND ACCESSORIES	Mar 22, 1996	Substantially Equivalent	Elekta Instruments, Inc.
K922064	MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE	Dec 01, 1992	Substantially Equivalent	Cardiotronics, Inc.
K901540	MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR	Apr 08, 1991	Substantially Equivalent	Radionics, Inc.
K896450	NEURO N 50 LESION GENERATOR	Mar 19, 1991	Substantially Equivalent	Leibinger & Fischer , Ltd.