GZF — Stimulator, Peripheral Nerve, Implanted (Pain Relief) Class II

FDA Device Classification

Classification Details

Product Code
GZF
Device Class
Class II
Regulation Number
882.5870
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243782bioventusStimTrial Neuromodulation SystemJuly 16, 2025
K243678bioventusTalisMann Neuromodulation SystemJuly 3, 2025
K232415boston scientific neuromodulationNalu Neurostimulation System for Peripheral Nerve StimulationAugust 21, 2024
K233162curonixFreedom Peripheral Nerve Stimulator (PNS) SystemJune 20, 2024
K221303neuspera medicalNeuspera Nuity SystemApril 11, 2023
K211965bionessStimRouter Neuromodulation SystemFebruary 23, 2022
K202781neuspera medicalNeuspera Neurostimulation System (NNS)August 27, 2021
K200848micron medical corporationStimulator, Stimulator Kit, External Transmitter, External Transmitter KitAugust 14, 2020
K200482bionessStimRouter Neuromodulation SystemMarch 27, 2020
K190047bionessStimRouter Neuromodulation SystemOctober 31, 2019
K191435nalu medicalIPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4September 6, 2019
K183579boston scientific neuromodulationNalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu NeurostimulMarch 29, 2019
K171366stimwave technologies inc., dba stimqReceiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG AcAugust 4, 2017
K152178stimqStimQ Peripheral Nerve Stimulator (PNS) SystemMarch 11, 2016
K142432bionessStimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRoFebruary 20, 2015
K000852advanced neuromodulation systemsRENEW NEUROSTIMULATION SYSTEMJanuary 19, 2001
K000105medtronic vascularMEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXApril 12, 2000
K982902medtronic vascularPERIPHERAL NERVE STIMULATIONNovember 10, 1998
K960631medtronic vascularMEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OXMay 21, 1996
K950425medtronic vascularTECOTHANE 55DApril 19, 1995