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GXD — Generator, Lesion, Radiofrequency Class II

FDA Device Classification

Classification Details

Product Code
GXD
Device Class
Class II
Regulation Number
882.4400
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251247boston scientific neuromodulation corporationGX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator KitAugust 7, 2025
K242057avanos medicalCOOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVAugust 14, 2024
K232632epimed internationalRacz Neurostat RF GeneratorMay 24, 2024
K231675neuroone medical technologiesOneRF Ablation SystemDecember 6, 2023
K220122rf innovationsAPEX 6March 15, 2023
K203293abbott medicalAbbott Medical Grounding Pad, model RF-DGP-ISJanuary 21, 2022
K201610abbott medicalIonicRF GeneratorOctober 21, 2020
K192491avanos medicalCoolief Radiofrequency Generator (CRG) SystemFebruary 21, 2020
K181864baylis medical companyPolaris RF Ablation SystemJanuary 2, 2019
K171143relievant medsystemsRelievant Medsystems RF GeneratorAugust 18, 2017
K170242stryker corporationMultiGen™ 2 RF Generator SystemMay 25, 2017
K101592cheng medical, corporationERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEMOctober 6, 2011
K111576neuro thermNT 2000 LESIONING GENERATORSeptember 20, 2011
K093185diros technologyOWL UNIVERSAL RF SYSTEM URF-3AP (ML)January 22, 2010
K082051cosman medicalCOSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4October 16, 2008
K081729bioform medicalMODIFICATION TO GFX NERVE ABLATION SYSTEMAugust 7, 2008
K071482synergeticsSTRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000December 20, 2007
K063753aciGFX NERVE ABLATION SYSTEMJune 20, 2007
K070336stockertSTOCKERT NEURO N50, MODEL12267June 14, 2007
K063489synergeticsSTRYKER INTRADISCAL RF GENERATORMay 23, 2007