GXD · Class II · 21 CFR 882.4400

FDA Product Code GXD: Generator, Lesion, Radiofrequency

Leading manufacturers include Avanos Medical, Inc., Abbott Medical and Neuroone Medical Technologies Corp..

37
Total
37
Cleared
200d
Avg days
1991
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 68d recently vs 208d 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 May 25, 2017
MultiGen™ 2 RF Generator System
K170242
Stryker Corporation
Neurology · 119d

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 - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - GXD Product Code

Recent submissions under GXD have taken an average of 68 days to reach a decision - down from 208 days historically, suggesting improved FDA processing for this classification.

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