GZBClass II

Stimulator, Spinal-Cord, Implanted (Pain Relief)

21 CFR 882.5880 / Neurology

GZB is the FDA product code for Stimulator, Spinal-Cord, Implanted (Pain Relief), a class II device type, regulated under 21 CFR 882.5880. As of 2026-09-10, FDA records hold 139 510(k) clearances under this code, the most recent dated 2024-08-23, and 5 recalls.

Classification record

Product code: GZB
Device name: Stimulator, Spinal-Cord, Implanted (Pain Relief)
Regulation: 21 CFR 882.5880
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: 139
Ingested recalls: 5

Clearances, product code GZB

By decision year

139 clearances under product code GZB with a decision year between 1978 and 2024, 1991 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code GZB by decision year
Year	Clearances
1978	2
1979	1
1980	2
1981	5
1982	2
1983	2
1984	2
1985	5
1986	4
1987	1
1988	2
1989	3
1990	2
1991	11
1992	4
1993	3
1994	8
1995	7
1996	3
1997	2
1998	2
1999	4
2000	2
2001	4
2002	3
2003	9
2004	3
2005	6
2006	2
2007	2
2008	1
2009	3
2010	1
2011	4
2012	2
2013	2
2014	2
2015	2
2016	2
2017	2
2018	1
2019	4
2020	2
2021	1
2022	1
2024	1

Applicants with the most clearances

Product code GZB

Applicants holding the most 510(k) clearances under product code GZB
Applicant	Clearances
Medtronic, Inc.	58
Abbott Medical	27
Neuromed, Inc.	15
Stimwave Technologies Incorporated	8
Boston Scientific Neuromodulation Corporation	7
Anulex Technologies, Inc.	4
Cordis US Corp.	3
Greatbatch Medical	2
Medtronic Neuromodulation	2
St. Jude Medical Neuromodulation	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order