GZB · Class II · 21 CFR 882.5880

FDA Product Code GZB: Stimulator, Spinal-cord, Implanted (pain Relief)

Leading manufacturers include Medtronic Vascular, Advanced Neuromodulation Systems and Stimwave Technologies Incorporated.

139
Total
139
Cleared
117d
Avg days
1978
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Stimulator, Spinal-cord, Implanted (pain Relief) Devices (Product Code GZB)

139 devices
1–24 of 139
Cleared Aug 23, 2024
Nalu Neurostimulation System for Spinal Cord Stimulation
K233801
Boston Scientific Neuromodulation
Neurology · 268d
Cleared Jun 10, 2022
Nalu Neurostimulation System
K221376
Boston Scientific Neuromodulation
Neurology · 29d
Cleared Mar 25, 2021
Nalu Neurostimulation System
K203547
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
K202274
Boston Scientific Neuromodulation
Neurology · 90d
Cleared Jul 15, 2020
Nalu Neurostimulation SCS system
K201618
Boston Scientific Neuromodulation
Neurology · 30d
Cleared Nov 07, 2019
SandShark Injectable Anchor (SIA) System
K191466
Stimwave Technologies, Inc.
Neurology · 157d
Cleared Jul 11, 2019
Nalu Lead Blank (50cm)
K190960
Boston Scientific Neuromodulation
Neurology · 90d
Cleared Mar 29, 2019
Freedom Spinal Cord Stimulator (SCS) System
K182720
Stimwave Technologies Incorporated
Neurology · 182d
Cleared Mar 22, 2019
Nalu Neurostimulation System
K183047
Boston Scientific Neuromodulation
Neurology · 140d
Cleared Sep 19, 2018
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
K180981
Stimwave Technologies Incorporated
Neurology · 159d
Cleared Nov 03, 2017
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base
K172644
Stimwave Technologies Incorporated
Neurology · 63d
Cleared May 02, 2017
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
K170141
Stimwave Technologies Incorporated
Neurology · 105d
Cleared Dec 16, 2016
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
K162161
Stimwave Technologies Incorporated
Neurology · 136d
Cleared Aug 26, 2016
Freedom Spinal Cord Stimulator System
K160600
Stimwave Technologies Incorporated
Neurology · 177d
Cleared Jul 27, 2015
A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
K150924
Anchor Innovation Medical (A.I.M.)
General & Plastic Surgery · 112d
Cleared Jun 05, 2015
Freedom Spinal Cord Stimulator System
K150517
Stimwave Technologies Incorporated
Neurology · 95d
Cleared Oct 10, 2014
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
K141399
Stimwave Technologies Incorporated
Neurology · 135d
Cleared May 02, 2014
SWIFT-LOCK ANCHOR
K140272
St Jude Medical
Neurology · 88d
Cleared Jun 18, 2013
MULTI LEAD TRIAL CABLE
K130545
St Jude Medical
Neurology · 109d
Cleared Jan 18, 2013
MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
K123299
St. Jude Medical Neuromodulation
Neurology · 87d
Cleared Apr 20, 2012
RAPID PROGRAMMER
K113611
St Jude Medical
Neurology · 136d
Cleared Feb 23, 2012
FIXATE TISSUE BAND
K113805
Anulex Technologies, Inc.
General & Plastic Surgery · 62d
Cleared Dec 16, 2011
FIXATE TISSUE BAND
K113400
Anulex Technologies, Inc.
General & Plastic Surgery · 29d
Cleared Nov 17, 2011
OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
K112214
St. Jude Medical Neuromodulation
Neurology · 107d

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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.