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510(k) K010008

Device
AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX
Applicant
MICRONET MEDICAL, INC.
510(k) number
K010008
Product code
GZB  
Decision
Substantially Equivalent (SESE)
Decision date
2001-07-16
Date received
2001-01-02
Regulation
882.5880
Classification name
Stimulator, Spinal-cord, Implanted (pain Relief)
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHARLES LEHMAN
Address
1839 Buerkle Rd. White Bear Lake, MN US 55110 55110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GZB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation2024-08-23
K221376Nalu Neurostimulation SystemBoston Scientific Neuromodulation2022-06-10
K203547Nalu Neurostimulation SystemBoston Scientific Neuromodulation2021-03-25
K202274Nalu 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 kitsBoston Scientific Neuromodulation2020-11-09
K201618Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation2020-07-15
K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.2019-11-07
K190960Nalu Lead Blank (50cm)Boston Scientific Neuromodulation2019-07-11
K182720Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated2019-03-29
K183047Nalu Neurostimulation SystemBoston Scientific Neuromodulation2019-03-22
K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitStimwave Technologies Incorporated2018-09-19
K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading BaseStimwave Technologies Incorporated2017-11-03
K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated2017-05-02
K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated2016-12-16
K160600Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated2016-08-26
K150924A.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 DeviceAnchor Innovation Medical (A.I.M.)2015-07-27

Legacy Summary#

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FDA Review#

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