FDA.report

510(k) K202781

Device
Neuspera Neurostimulation System (NNS)
Applicant
Neuspera Medical, Inc.
510(k) number
K202781
Product code
GZF
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-27
Date received
2020-09-22
Regulation
882.5870
Classification name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Alexander Yeh
Address
51 Daggett Dr. San Jose CA US 95134 95134

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code GZF

510(k)DeviceApplicantDecision date
K243782StimTrial Neuromodulation SystemBioventus, LLC2025-07-16
K243678TalisMann Neuromodulation SystemBioventus, LLC2025-07-03
K232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation2024-08-21
K233162Freedom Peripheral Nerve Stimulator (PNS) SystemCuronix2024-06-20
K221303Neuspera Nuity SystemNeuspera Medical, Inc.2023-04-11
K211965StimRouter Neuromodulation SystemBioness, Inc.2022-02-23
K200848Stimulator, Stimulator Kit, External Transmitter, External Transmitter KitMicron Medical Corporation2020-08-14
K200482StimRouter Neuromodulation SystemBioness, Inc.2020-03-27
K190047StimRouter Neuromodulation SystemBioness, Inc.2019-10-31
K191435IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4Nalu Medical, Inc.2019-09-06
K183579Nalu 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 kitsBoston Scientific Neuromodulation2019-03-29
K171366Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger KitStimwave Technologies Inc., Dba Stimq, LLC2017-08-04
K152178StimQ Peripheral Nerve Stimulator (PNS) SystemStimq, LLC2016-03-11
K142432StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User KitBioness, Inc.2015-02-20
K000852RENEW NEUROSTIMULATION SYSTEMAdvanced Neuromodulation Systems2001-01-19