FDA Product Code GZB: Stimulator, Spinal-cord, Implanted (pain Relief)
Leading manufacturers include Medtronic Vascular, Boston Scientific Neuromodulation and Cordis Corp..
139
Total
139
Cleared
117d
Avg days
1978
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
268d
recently vs 116d historically
FDA 510(k) Cleared Stimulator, Spinal-cord, Implanted (pain Relief) Devices (Product Code GZB)
139 devices
Cleared
Aug 23, 2024
Nalu Neurostimulation System for Spinal Cord Stimulation
Boston Scientific Neuromodulation
Neurology
268d
Cleared
Jun 10, 2022
Nalu Neurostimulation System
Boston Scientific Neuromodulation
Neurology
29d
Cleared
Mar 25, 2021
Nalu Neurostimulation System
Boston Scientific Neuromodulation
Neurology
111d
Cleared
Nov 09, 2020
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
Boston Scientific Neuromodulation
Neurology
90d
Cleared
Jul 15, 2020
Nalu Neurostimulation SCS system
Boston Scientific Neuromodulation
Neurology
30d
Cleared
Nov 07, 2019
SandShark Injectable Anchor (SIA) System
Stimwave Technologies, Inc.
Neurology
157d
Cleared
Jul 11, 2019
Nalu Lead Blank (50cm)
Boston Scientific Neuromodulation
Neurology
90d
Cleared
Mar 29, 2019
Freedom Spinal Cord Stimulator (SCS) System
Stimwave Technologies Incorporated
Neurology
182d
Cleared
Mar 22, 2019
Nalu Neurostimulation System
Boston Scientific Neuromodulation
Neurology
140d
Cleared
Sep 19, 2018
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
Stimwave Technologies Incorporated
Neurology
159d
Cleared
Mar 25, 2004
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
Medtronic Vascular
Neurology
21d
Cleared
Sep 11, 2003
RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR
Medtronic Vascular
Neurology
22d
Cleared
Aug 01, 2001
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
Medtronic Vascular
Neurology
181d
Cleared
Jun 22, 2001
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
Medtronic Vascular
Neurology
30d
Cleared
Apr 28, 2000
MEDTRONIC MODEL 7499 EXTENSION
Medtronic Vascular
Neurology
78d
Cleared
Feb 09, 1999
MEDTRONIC MODEL 7495 EXTENSION KIT
Medtronic Vascular
Neurology
28d
Cleared
Feb 06, 1998
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)
Medtronic Vascular
Neurology
184d
Cleared
Feb 03, 1998
MEDTRONIC MODEL 3998 LEAD
Medtronic Vascular
Neurology
267d
Cleared
Aug 22, 1997
MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
Medtronic Vascular
Neurology
81d
Cleared
Jul 03, 1997
MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL
Medtronic Vascular
Neurology
258d
Cleared
Nov 19, 1996
BIFURCATED Y-EXTENSION
Medtronic Vascular
Neurology
469d
Cleared
May 17, 1996
DUALSCREEN
Medtronic Vascular
Neurology
183d
Cleared
Nov 27, 1995
MODEL NOS. 7495 AND 501826 EXTENSIONS
Medtronic Vascular
Neurology
151d
Cleared
Aug 30, 1995
MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL
Medtronic Vascular
Neurology
96d
About Product Code GZB - Regulatory Context
510(k) Submission Activity
139 total 510(k) submissions under product code GZB since 1978, with 139 receiving FDA clearance (average review time: 117 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - GZB Product Code
Recent submissions under GZB have taken an average of 268 days to reach a decision - up from 116 days historically. Manufacturers should account for longer review timelines in current project planning.
GZB devices are reviewed by the Neurology panel. Browse all Neurology devices →