Atlas FDA

GXD

37 FDA 510(k) clearances · Product code

141 daysmedian time to decision
486 days90th percentile
37clearances measured

FDA profile

Official device name
Generator, Lesion, Radiofrequency
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4400
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 154 · 2022: 84 · 2023: 54 · 2024: 63 · 2025: 88 · 2026: 33
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
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) (K251247)Boston Scientific Neuromodulation Corporation2025-08-07
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) (K242057)Avanos Medical, Inc.2024-08-14
Racz Neurostat RF Generator (K232632)Epimed International2024-05-24
OneRF Ablation System (K231675)Neuroone Medical Technologies Corp.2023-12-06
APEX 6 (K220122)Rf Innovations, Inc.2023-03-15
Abbott Medical Grounding Pad, model RF-DGP-IS (K203293)ABBOTT MEDICAL2022-01-21
IonicRF Generator (K201610)ABBOTT MEDICAL2020-10-21
Coolief Radiofrequency Generator (CRG) System (K192491)Avanos Medical, Inc.2020-02-21
Polaris RF Ablation System (K181864)Baylis Medical Company, Inc.2019-01-02
Relievant Medsystems RF Generator (K171143)Relievant Medsystems2017-08-18
MultiGen™ 2 RF Generator System (K170242)Stryker Corporation2017-05-25
ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM (K101592)Cheng Medical, Corporation2011-10-06
NT 2000 LESIONING GENERATOR (K111576)Neuro Therm, Inc.2011-09-20
OWL UNIVERSAL RF SYSTEM URF-3AP (ML) (K093185)Diros Technology, Inc.2010-01-22
COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 (K082051)Cosman Medical, Inc.2008-10-16
MODIFICATION TO GFX NERVE ABLATION SYSTEM (K081729)Bioform Medical, Inc.2008-08-07
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 (K071482)Synergetics, Inc.2007-12-20
GFX NERVE ABLATION SYSTEM (K063753)Aci, Inc.2007-06-20
STOCKERT NEURO N50, MODEL12267 (K070336)Stockert GmbH2007-06-14
STRYKER INTRADISCAL RF GENERATOR (K063489)Synergetics, Inc.2007-05-23
OWL URF-3AP (K062758)Diros Technology, Inc.2006-09-27
NT-1000 (K052878)Neuro Therm, Inc.2006-01-23
PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE (K040565)Physician Industries, Inc.2004-07-22
STRYKER INTERVENTIONAL PAIN RF GENERATOR (K032601)Valley Forge Scientific Corp.2004-04-01
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP (K021869)Diros Technology, Inc.2002-07-01
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) (K020354)Baylis Medical Co., Inc.2002-05-03
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES (K010202)Leslie W. Organ2001-10-31
BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE) (K002565)Baylis Medical Co., Inc.2001-05-03
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES (K010969)Stryker Instruments2001-04-20
RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES (K983214)Rita Medical Systems2000-03-27
RFG-3C PLUS (K982489)Radionics, Inc.1998-10-05
RFG-3CF (K965182)Radionics, Inc.1997-03-12
RADIONICS SLUIJTER-MEHTA CANNULA (K963577)Radionics, Inc.1996-11-21
LEKSELL NEURO GENERATOR AND ACCESSORIES (K941823)Elekta Instruments, Inc.1996-03-22
MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE (K922064)Cardiotronics, Inc.1992-12-01
MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR (K901540)Radionics, Inc.1991-04-08
NEURO N 50 LESION GENERATOR (K896450)Leibinger & Fischer , Ltd.1991-03-19

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Every clearance here is in the API, with alerts when new ones post.