GWNClass II

Nystagmograph

21 CFR 882.1460 / Neurology

GWN is the FDA product code for Nystagmograph, a class II device type, regulated under 21 CFR 882.1460. As of 2026-09-10, FDA records hold 60 510(k) clearances under this code, the most recent dated 2026-07-30, and 4 recalls.

Classification record

Product code: GWN
Device name: Nystagmograph
Regulation: 21 CFR 882.1460
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: 60
Ingested recalls: 4

Clearances, product code GWN

By decision year

60 clearances under product code GWN with a decision year between 1981 and 2026, 1997 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code GWN by decision year
Year	Clearances
1981	1
1982	3
1983	1
1984	3
1985	2
1986	1
1987	2
1988	1
1992	1
1994	2
1995	1
1997	4
1998	1
1999	3
2001	3
2004	1
2005	1
2006	2
2007	2
2008	1
2009	1
2013	3
2015	3
2016	2
2017	4
2018	3
2019	1
2020	2
2023	1
2025	3
2026	1

Applicants with the most clearances

Product code GWN

Applicants holding the most 510(k) clearances under product code GWN
Applicant	Clearances
Interacoustics a/S	5
Natus Medical Denmark ApS	4
Spryson America Inc	4
Ics Medical Corp.	3
Micromedical Technologies, Inc.	3
Philadelphia Medical Specialties	3
Bio-Logic Systems Corp.	2
Fall Prevention Technologies, LLC	2
Kelleher Corp.	2
Synapsys, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order