JXGClass II

Shunt, Central Nervous System And Components

21 CFR 882.5550 / Neurology

JXG is the FDA product code for Shunt, Central Nervous System And Components, a class II device type, regulated under 21 CFR 882.5550. As of 2026-09-10, FDA records hold 259 510(k) clearances under this code, the most recent dated 2026-06-23, and 108 recalls.

Classification record

Product code: JXG
Device name: Shunt, Central Nervous System And Components
Regulation: 21 CFR 882.5550
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 259
Ingested recalls: 108

Clearances, product code JXG

By decision year

259 clearances under product code JXG with a decision year between 1976 and 2026, 2004 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code JXG by decision year
Year	Clearances
1976	4
1978	1
1979	5
1980	4
1981	2
1982	4
1983	4
1984	3
1985	11
1986	7
1987	4
1988	6
1989	4
1990	6
1991	7
1992	7
1993	3
1994	4
1995	5
1996	9
1997	11
1998	7
1999	8
2000	9
2002	8
2003	9
2004	15
2005	3
2006	6
2007	3
2008	6
2009	5
2010	3
2011	7
2012	3
2013	3
2015	6
2016	6
2017	7
2018	6
2019	4
2020	2
2021	1
2022	4
2023	5
2024	3
2025	8
2026	1

Applicants with the most clearances

Product code JXG

Applicants holding the most 510(k) clearances under product code JXG
Applicant	Clearances
Cerenovus, Inc.	23
Holter-Hausner Intl.	21
Cordis US Corp.	18
Medtronic Neurosurgery	18
Pudenz-Schulte Medical Research Corp.	18
Integra LifeSciences Corporation	14
Aesculap Inc	13
Phoenix Biomedical Corp.	13
Radionics, Inc.	10
Sophysa	10

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 61 companies shown, in name order