GXDClass II

Generator, Lesion, Radiofrequency

21 CFR 882.4400 / Neurology

GXD is the FDA product code for Generator, Lesion, Radiofrequency, a class II device type, regulated under 21 CFR 882.4400. As of 2026-09-10, FDA records hold 37 510(k) clearances under this code, the most recent dated 2025-08-07, and 7 recalls.

Classification record

Product code: GXD
Device name: Generator, Lesion, Radiofrequency
Regulation: 21 CFR 882.4400
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 37
Ingested recalls: 7

Clearances, product code GXD

By decision year

37 clearances under product code GXD with a decision year between 1991 and 2025, 2007 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code GXD by decision year
Year	Clearances
1991	2
1992	1
1996	2
1997	1
1998	1
2000	1
2001	3
2002	2
2004	2
2006	2
2007	4
2008	2
2010	1
2011	2
2017	2
2019	1
2020	2
2022	1
2023	2
2024	2
2025	1

Applicants with the most clearances

Product code GXD

Applicants holding the most 510(k) clearances under product code GXD
Applicant	Clearances
Radionics, Inc.	4
Baylis Medical Co., Inc.	3
Diros Technology, Inc.	3
Abbott Medical	2
Halyard Health	2
Boston Scientific Neuromodulation Corporation	2
Neuro Therm, Inc.	2
Stryker Corp.	2
Synergetics Inc	2
Aci, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 42 companies shown, in name order