GXD · Class II · 21 CFR 882.4400

FDA Product Code GXD: Generator, Lesion, Radiofrequency

Leading manufacturers include Radionics, Inc., Baylis Medical Co., Inc. and Neuro Therm, Inc..

37
Total
37
Cleared
200d
Avg days
1991
Since
Declining activity - 1 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 106d recently vs 203d historically

FDA 510(k) Cleared Generator, Lesion, Radiofrequency Devices (Product Code GXD)

37 devices
1–24 of 37
Cleared Aug 07, 2025
GX1 Radiofrequency Generator Kit (RFG-X1-120V)
K251247
Boston Scientific Neuromodulation Corporation
Neurology · 106d
Cleared Aug 14, 2024
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
K242057
Avanos Medical, Inc.
Neurology · 30d
Cleared May 24, 2024
Racz Neurostat RF Generator
K232632
Epimed International
Neurology · 268d
Cleared Dec 06, 2023
OneRF Ablation System
K231675
Neuroone Medical Technologies Corp.
Neurology · 181d
Cleared Mar 15, 2023
APEX 6
K220122
Rf Innovations, Inc.
Neurology · 421d
Cleared Jan 21, 2022
Abbott Medical Grounding Pad, model RF-DGP-IS
K203293
Abbott Medical
Neurology · 438d
Cleared Oct 21, 2020
IonicRF Generator
K201610
Abbott Medical
Neurology · 128d
Cleared Feb 21, 2020
Coolief Radiofrequency Generator (CRG) System
K192491
Avanos Medical, Inc.
Neurology · 163d
Cleared Jan 02, 2019
Polaris RF Ablation System
K181864
Baylis Medical Company, Inc.
Neurology · 174d
Cleared Aug 18, 2017
Relievant Medsystems RF Generator
K171143
Relievant Medsystems
Neurology · 122d
Cleared May 25, 2017
MultiGen™ 2 RF Generator System
K170242
Stryker Corporation
Neurology · 119d
Cleared Sep 20, 2011
NT 2000 LESIONING GENERATOR
K111576
Neuro Therm, Inc.
Neurology · 106d
Cleared Oct 16, 2008
COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
K082051
Cosman Medical, Inc.
Neurology · 90d
Cleared Aug 07, 2008
MODIFICATION TO GFX NERVE ABLATION SYSTEM
K081729
Bioform Medical, Inc.
Neurology · 50d
Cleared Dec 20, 2007
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
K071482
Synergetics, Inc.
Neurology · 204d
Cleared Jun 20, 2007
GFX NERVE ABLATION SYSTEM
K063753
Aci, Inc.
Neurology · 183d
Cleared Jun 14, 2007
STOCKERT NEURO N50, MODEL12267
K070336
Stockert GmbH
Neurology · 129d
Cleared May 23, 2007
STRYKER INTRADISCAL RF GENERATOR
K063489
Synergetics, Inc.
Neurology · 187d
Cleared Sep 27, 2006
OWL URF-3AP
K062758
Diros Technology, Inc.
Neurology · 12d
Cleared Jan 23, 2006
NT-1000
K052878
Neuro Therm, Inc.
Neurology · 103d
Cleared Apr 01, 2004
STRYKER INTERVENTIONAL PAIN RF GENERATOR
K032601
Valley Forge Scientific Corp.
Neurology · 220d
Cleared May 03, 2002
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
K020354
Baylis Medical Co., Inc.
Neurology · 88d
Cleared May 03, 2001
BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)
K002565
Baylis Medical Co., Inc.
Neurology · 259d
Cleared Apr 20, 2001
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
K010969
Stryker Instruments
Neurology · 18d

About Product Code GXD - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code GXD since 1991, with 37 receiving FDA clearance (average review time: 200 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - GXD Product Code

Recent submissions under GXD have taken an average of 106 days to reach a decision - down from 203 days historically, suggesting improved FDA processing for this classification.

GXD devices are reviewed by the Neurology panel. Browse all Neurology devices →