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Panels › Neurology › Product code GXD · Class 2

Generator, Lesion, Radiofrequency

Regulation 882.4400

0510(k)s in 12 months (37 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in GXD

Company510(k)sRecalls
Radionics, Inc.40
ABBOTT MEDICAL21
Avanos Medical, Inc.21
Baylis Medical Co., Inc.30
Diros Technology, Inc.30
Neuro Therm, Inc.20
Stryker Instruments Div. of Stryker Corporation02
Synergetics, Inc.20
Abbott01
Abbott Laboratories Inc. (St Jude Medical)01
Decided510(k)Device and applicantCode
Aug 7, 2025K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Gener
Boston Scientific Neuromodulation Corporation
GXD
Aug 14, 2024K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
Avanos Medical, Inc.
GXD
May 24, 2024K232632Racz Neurostat RF Generator
Epimed International
GXD
Dec 6, 2023K231675OneRF Ablation System
Neuroone Medical Technologies Corp.
GXD
Mar 15, 2023K220122APEX 6
Rf Innovations, Inc.
GXD
Jan 21, 2022K203293Abbott Medical Grounding Pad, model RF-DGP-IS
ABBOTT MEDICAL
GXD
Oct 21, 2020K201610IonicRF Generator
ABBOTT MEDICAL
GXD
Feb 21, 2020K192491Coolief Radiofrequency Generator (CRG) System
Avanos Medical, Inc.
GXD
Jan 2, 2019K181864Polaris RF Ablation System
Baylis Medical Company, Inc., CA
GXD
Aug 18, 2017K171143Relievant Medsystems RF Generator
Relievant Medsystems
GXD
May 25, 2017K170242MultiGen™ 2 RF Generator System
Stryker Corporation
GXD
Oct 6, 2011K101592ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM
Cheng Medical, Corporation
GXD
Sep 20, 2011K111576NT 2000 LESIONING GENERATOR
Neuro Therm, Inc.
GXD
Jan 22, 2010K093185OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
Diros Technology, Inc., CA
GXD
Oct 16, 2008K082051COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
Cosman Medical, Inc.
GXD
Aug 7, 2008K081729MODIFICATION TO GFX NERVE ABLATION SYSTEM
Bioform Medical, Inc.
GXD
Dec 20, 2007K071482STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
Synergetics, Inc.
GXD
Jun 20, 2007K063753GFX NERVE ABLATION SYSTEM
Aci, Inc.
GXD
Jun 14, 2007K070336STOCKERT NEURO N50, MODEL12267
Stockert GmbH, DE
GXD
May 23, 2007K063489STRYKER INTRADISCAL RF GENERATOR
Synergetics, Inc.
GXD
Sep 27, 2006K062758OWL URF-3AP
Diros Technology, Inc., CA
GXD
Jan 23, 2006K052878NT-1000
Neuro Therm, Inc.
GXD
Jul 22, 2004K040565PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE
Physician Industries, Inc.
GXD
Apr 1, 2004K032601STRYKER INTERVENTIONAL PAIN RF GENERATOR
Valley Forge Scientific Corp.
GXD
Jul 1, 2002K021869OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
Diros Technology, Inc.
GXD
May 3, 2002K020354BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
Baylis Medical Co., Inc., CA
GXD
Oct 31, 2001K010202OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES
Leslie W. Organ
GXD
May 3, 2001K002565BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)
Baylis Medical Co., Inc., CA
GXD
Apr 20, 2001K010969NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
Stryker Instruments
GXD
Mar 27, 2000K983214RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
Rita Medical Systems
GXD
Oct 5, 1998K982489RFG-3C PLUS
Radionics, Inc.
GXD
Mar 12, 1997K965182RFG-3CF
Radionics, Inc.
GXD
Nov 21, 1996K963577RADIONICS SLUIJTER-MEHTA CANNULA
Radionics, Inc.
GXD
Mar 22, 1996K941823LEKSELL NEURO GENERATOR AND ACCESSORIES
Elekta Instruments, Inc.
GXD
Dec 1, 1992K922064MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE
Cardiotronics, Inc.
GXD
Apr 8, 1991K901540MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR
Radionics, Inc.
GXD
Mar 19, 1991K896450NEURO N 50 LESION GENERATOR
Leibinger & Fischer , Ltd.
GXD

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