GWMClass II

Device, Monitoring, Intracranial Pressure

21 CFR 882.1620 / Neurology

GWM is the FDA product code for Device, Monitoring, Intracranial Pressure, a class II device type, regulated under 21 CFR 882.1620. As of 2026-09-10, FDA records hold 105 510(k) clearances under this code, the most recent dated 2026-04-10, and 52 recalls.

Classification record

Product code: GWM
Device name: Device, Monitoring, Intracranial Pressure
Regulation: 21 CFR 882.1620
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: 105
Ingested recalls: 52

Clearances, product code GWM

By decision year

105 clearances under product code GWM with a decision year between 1978 and 2026, 1988 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code GWM by decision year
Year	Clearances
1978	1
1979	1
1980	5
1981	1
1982	2
1984	2
1985	2
1986	4
1987	1
1988	7
1989	2
1990	2
1992	2
1993	1
1994	2
1995	3
1996	1
1998	3
1999	4
2000	2
2001	3
2002	7
2003	2
2004	2
2005	4
2006	3
2007	2
2008	2
2009	1
2010	2
2011	3
2012	4
2013	2
2014	2
2016	3
2017	3
2018	1
2019	2
2020	3
2021	2
2024	2
2025	1
2026	1

Applicants with the most clearances

Product code GWM

Applicants holding the most 510(k) clearances under product code GWM
Applicant	Clearances
Cerenovus, Inc.	9
Integra LifeSciences Corporation	8
Innerspace, Inc.	7
Raumedic AG	6
Integra NeuroSciences	5
Metatech Corp.	5
Camino Laboratories, Inc.	4
Cma Microdialysis AB	4
Braincare Desenvolvimento e Inovacao Tecnologica S.A.	3
Camino Neurocare, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 61 companies shown, in name order