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Generator, Lesion, Radiofrequency

FDA product code GXD · 37 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.4400
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1991-03-19 – 2025-08-07

GXD 2025-08-07

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)

Applicant Boston Scientific Neuromodulation Corporation

K number K251247

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GXD 2024-08-14

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

Applicant Avanos Medical, Inc.

K number K242057

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GXD 2024-05-24

Racz Neurostat RF Generator

Applicant Epimed International

K number K232632

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GXD 2023-12-06

OneRF Ablation System

Applicant Neuroone Medical Technologies Corp.

K number K231675

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GXD 2023-03-15

APEX 6

Applicant Rf Innovations, Inc.

K number K220122

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GXD 2022-01-21

Abbott Medical Grounding Pad, model RF-DGP-IS

Applicant ABBOTT MEDICAL

K number K203293

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GXD 2020-10-21

IonicRF Generator

Applicant ABBOTT MEDICAL

K number K201610

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GXD 2020-02-21

Coolief Radiofrequency Generator (CRG) System

Applicant Avanos Medical, Inc.

K number K192491

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GXD 2019-01-02

Polaris RF Ablation System

Applicant Baylis Medical Company, Inc.

K number K181864

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GXD 2017-08-18

Relievant Medsystems RF Generator

Applicant Relievant Medsystems

K number K171143

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GXD 2017-05-25

MultiGen™ 2 RF Generator System

Applicant Stryker Corporation

K number K170242

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GXD 2011-10-06

ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM

Applicant Cheng Medical, Corporation

K number K101592

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GXD 2011-09-20

NT 2000 LESIONING GENERATOR

Applicant Neuro Therm, Inc.

K number K111576

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GXD 2010-01-22

OWL UNIVERSAL RF SYSTEM URF-3AP (ML)

Applicant Diros Technology, Inc.

K number K093185

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GXD 2008-10-16

COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4

Applicant Cosman Medical, Inc.

K number K082051

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GXD 2008-08-07

MODIFICATION TO GFX NERVE ABLATION SYSTEM

Applicant Bioform Medical, Inc.

K number K081729

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GXD 2007-12-20

STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000

Applicant Synergetics, Inc.

K number K071482

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GXD 2007-06-20

GFX NERVE ABLATION SYSTEM

Applicant Aci, Inc.

K number K063753

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GXD 2007-06-14

STOCKERT NEURO N50, MODEL12267

Applicant Stockert GmbH

K number K070336

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GXD 2007-05-23

STRYKER INTRADISCAL RF GENERATOR

Applicant Synergetics, Inc.

K number K063489

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GXD 2006-09-27

OWL URF-3AP

Applicant Diros Technology, Inc.

K number K062758

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GXD 2006-01-23

NT-1000

Applicant Neuro Therm, Inc.

K number K052878

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GXD 2004-07-22

PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE

Applicant Physician Industries, Inc.

K number K040565

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GXD 2004-04-01

STRYKER INTERVENTIONAL PAIN RF GENERATOR

Applicant Valley Forge Scientific Corp.

K number K032601

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GXD 2002-07-01

OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP

Applicant Diros Technology, Inc.

K number K021869

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GXD 2002-05-03

BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)

Applicant Baylis Medical Co., Inc.

K number K020354

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GXD 2001-10-31

OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES

Applicant Leslie W. Organ

K number K010202

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GXD 2001-05-03

BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)

Applicant Baylis Medical Co., Inc.

K number K002565

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GXD 2001-04-20

NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES

Applicant Stryker Instruments

K number K010969

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GXD 2000-03-27

RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES

Applicant Rita Medical Systems

K number K983214

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GXD 1998-10-05

RFG-3C PLUS

Applicant Radionics, Inc.

K number K982489

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GXD 1997-03-12

RFG-3CF

Applicant Radionics, Inc.

K number K965182

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GXD 1996-11-21

RADIONICS SLUIJTER-MEHTA CANNULA

Applicant Radionics, Inc.

K number K963577

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GXD 1996-03-22

LEKSELL NEURO GENERATOR AND ACCESSORIES

Applicant Elekta Instruments, Inc.

K number K941823

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GXD 1992-12-01

MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE

Applicant Cardiotronics, Inc.

K number K922064

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GXD 1991-04-08

MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR

Applicant Radionics, Inc.

K number K901540

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GXD 1991-03-19

NEURO N 50 LESION GENERATOR

Applicant Leibinger & Fischer , Ltd.

K number K896450

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