GZF · Class II · 21 CFR 882.5870

FDA Product Code GZF: Stimulator, Peripheral Nerve, Implanted (pain Relief)

Leading manufacturers include Medtronic Vascular, Bioness, Inc. and Bioventus, LLC.

25
Total
25
Cleared
184d
Avg days
1991
Since
Stable submission activity - 3 submissions in the last 2 years
Review times increasing: avg 234d recently vs 178d historically

FDA 510(k) Cleared Stimulator, Peripheral Nerve, Implanted (pain Relief) Devices (Product Code GZF)

25 devices
1–24 of 25
Cleared Aug 26, 2026
StimTrial Neuromodulation System
K253877
Bioventus, LLC
Neurology · 265d
Cleared Jul 16, 2025
StimTrial Neuromodulation System
K243782
Bioventus, LLC
Neurology · 219d
Cleared Jul 03, 2025
TalisMann Neuromodulation System
K243678
Bioventus, LLC
Neurology · 218d
Cleared Aug 21, 2024
Nalu Neurostimulation System for Peripheral Nerve Stimulation
K232415
Boston Scientific Neuromodulation
Neurology · 376d
Cleared Jun 20, 2024
Freedom Peripheral Nerve Stimulator (PNS) System
K233162
Curonix
Neurology · 267d
Cleared Apr 11, 2023
Neuspera Nuity System
K221303
Neuspera Medical, Inc.
Neurology · 341d
Cleared Feb 23, 2022
StimRouter Neuromodulation System
K211965
Bioness, Inc.
Neurology · 244d
Cleared Aug 27, 2021
Neuspera Neurostimulation System (NNS)
K202781
Neuspera Medical, Inc.
Neurology · 339d
Cleared Aug 14, 2020
Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
K200848
Micron Medical Corporation
Neurology · 136d
Cleared Mar 27, 2020
StimRouter Neuromodulation System
K200482
Bioness, Inc.
Neurology · 29d
Cleared Oct 31, 2019
StimRouter Neuromodulation System
K190047
Bioness, Inc.
Neurology · 295d
Cleared Sep 06, 2019
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4
K191435
Nalu Medical, Inc.
Neurology · 99d
Cleared Mar 29, 2019
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
K183579
Boston Scientific Neuromodulation
Neurology · 98d
Cleared Aug 04, 2017
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
K171366
Stimwave Technologies Inc., Dba Stimq, LLC
Neurology · 87d
Cleared Mar 11, 2016
StimQ Peripheral Nerve Stimulator (PNS) System
K152178
Stimq, LLC
Neurology · 220d
Cleared Feb 20, 2015
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
K142432
Bioness, Inc.
Neurology · 175d
Cleared Jan 19, 2001
RENEW NEUROSTIMULATION SYSTEM
K000852
Advanced Neuromodulation Systems
Neurology · 310d
Cleared Apr 12, 2000
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38
K000105
Medtronic Vascular
Neurology · 89d
Cleared Nov 10, 1998
PERIPHERAL NERVE STIMULATION
K982902
Medtronic Vascular
Neurology · 88d
Cleared May 21, 1996
MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX
K960631
Medtronic Vascular
Neurology · 97d
Cleared Apr 19, 1995
TECOTHANE 55D
K950425
Medtronic Vascular
Neurology · 76d
Cleared Aug 20, 1993
MEDTRONIC MODEL 3990 PNS LEAD
K925952
Medtronic Vascular
Neurology · 269d
Cleared May 20, 1992
MODELS 3987 AND 3988 RESUME LEAD FOR PNS
K920567
Medtronic Vascular
Neurology · 103d
Cleared Jan 22, 1992
MODEL 3587A RESUME II LEAD
K915540
Medtronic Vascular
Neurology · 43d

About Product Code GZF - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code GZF since 1991, with 25 receiving FDA clearance (average review time: 184 days).

Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - GZF Product Code

Recent submissions under GZF have taken an average of 234 days to reach a decision - up from 178 days historically. Manufacturers should account for longer review timelines in current project planning.

GZF devices are reviewed by the Neurology panel. Browse all Neurology devices →