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510(k) K201618

Device
Nalu Neurostimulation SCS System
Applicant
Nalu Medical, Inc
510(k) number
K201618
Product code
GZB  
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-15
Date received
2020-06-15
Regulation
882.5880
Classification name
Stimulator, Spinal-cord, Implanted (pain Relief)
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kaoru Lee Adair
Address
24155 Rye Canyon Loop Valencia CA US 91355 91355

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
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
K150517Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated2015-06-05

Legacy Summary#

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FDA Review#

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