GZB — Stimulator, Spinal-Cord, Implanted (Pain Relief) Class II

FDA Device Classification

Classification Details

Product Code
GZB
Device Class
Class II
Regulation Number
882.5880
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233801boston scientific neuromodulationNalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation August 23, 2024
K221376boston scientific neuromodulationNalu Neurostimulation SystemJune 10, 2022
K203547boston scientific neuromodulationNalu Neurostimulation SystemMarch 25, 2021
K202274boston scientific neuromodulationNalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu NeurostimulaNovember 9, 2020
K201618boston scientific neuromodulationNalu Neurostimulation SCS systemJuly 15, 2020
K191466stimwave technologiesSandShark Injectable Anchor (SIA) SystemNovember 7, 2019
K190960boston scientific neuromodulationNalu Lead Blank (50cm)July 11, 2019
K182720stimwave technologies incorporatedFreedom Spinal Cord Stimulator (SCS) SystemMarch 29, 2019
K183047boston scientific neuromodulationNalu Neurostimulation SystemMarch 22, 2019
K180981stimwave technologies incorporatedStimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitSeptember 19, 2018
K172644stimwave technologies incorporatedSandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, November 3, 2017
K170141stimwave technologies incorporatedReceiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna May 2, 2017
K162161stimwave technologies incorporatedReceiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna December 16, 2016
K160600stimwave technologies incorporatedFreedom Spinal Cord Stimulator SystemAugust 26, 2016
K150924anchor innovation medical (a.i.m.)A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter DeviceJuly 27, 2015
K150517stimwave technologies incorporatedFreedom Spinal Cord Stimulator SystemJune 5, 2015
K141399stimwave technologies incorporatedFREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEMOctober 10, 2014
K140272st jude medicalSWIFT-LOCK ANCHORMay 2, 2014
K130545st jude medicalMULTI LEAD TRIAL CABLEJune 18, 2013
K123299st. jude medical neuromodulationMTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADSJanuary 18, 2013