GXIClass II

Probe, Radiofrequency Lesion

21 CFR 882.4725 / Neurology

GXI is the FDA product code for Probe, Radiofrequency Lesion, a class II device type, regulated under 21 CFR 882.4725. As of 2026-09-10, FDA records hold 66 510(k) clearances under this code, the most recent dated 2026-04-16, and 29 recalls.

Classification record

Product code: GXI
Device name: Probe, Radiofrequency Lesion
Regulation: 21 CFR 882.4725
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: 66
Ingested recalls: 29

Clearances, product code GXI

By decision year

66 clearances under product code GXI with a decision year between 1980 and 2026, 1988 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code GXI by decision year
Year	Clearances
1980	1
1987	1
1988	5
1998	2
1999	1
2000	4
2001	1
2002	1
2003	1
2004	4
2005	3
2006	4
2007	4
2008	2
2009	2
2010	2
2011	3
2012	1
2013	1
2014	1
2015	1
2016	3
2017	3
2018	1
2019	3
2020	3
2022	2
2025	4
2026	2

Applicants with the most clearances

Product code GXI

Applicants holding the most 510(k) clearances under product code GXI
Applicant	Clearances
Baylis Medical Co., Inc.	7
Relievant Medsystems	6
Diros Technology, Inc.	5
Boston Scientific Neuromodulation Corporation	4
Smith & Nephew, Inc.	4
Stryker Corp.	4
Advanced Surgical Products, Inc.	3
Halyard Health	3
Lccs Products Limited	3
Radionics, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 68 companies shown, in name order