Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Neuspera Neurostimulation System (NNS)

K-Number: K202781 · 2021-08-27

ApplicantNeuspera Medical, Inc.
Decision Date2021-08-27
Product CodeGZF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neuspera Neurostimulation System (NNS) is a medical device manufactured by Neuspera Medical, Inc.. It received FDA 510(k) clearance on 2021-08-27 under approval number K202781. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuspera Neurostimulation System (NNS)?

Neuspera Neurostimulation System (NNS) is a medical device that received FDA 510(k) clearance on 2021-08-27. It is manufactured by Neuspera Medical, Inc.. The 510(k) number is K202781.

When was Neuspera Neurostimulation System (NNS) approved by the FDA?

Neuspera Neurostimulation System (NNS) received FDA 510(k) clearance on 2021-08-27, under approval number K202781.

What company makes Neuspera Neurostimulation System (NNS)?

Neuspera Neurostimulation System (NNS) is manufactured by Neuspera Medical, Inc..

What is the FDA product code for Neuspera Neurostimulation System (NNS)?

The FDA product code for Neuspera Neurostimulation System (NNS) is GZF.

Related Clinical Trials

NCT07301346 EASEE® System Pivotal Study for the United States of America NOT_YET_RECRUITING NCT05343988 Percutaneous Neurostimulation to Treat Paroxysmal Sympathetic Hyperactivity in Children TERMINATED NCT06782360 Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation COMPLETED

Other Devices by Neuspera Medical, Inc.

K221303Neuspera Nuity System PMA P240031Stimulator, electrical, implantable, for incontinence

Related Devices (Code: GZF)

K152178StimQ Peripheral Nerve Stimulator (PNS) SystemStimq, LLC K171366Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger KitStimwave Technologies Inc., Dba Stimq, LLC K190047StimRouter Neuromodulation SystemBioness, Inc. K191435IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4Nalu Medical, Inc. 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 Neuromodulation K200848Stimulator, Stimulator Kit, External Transmitter, External Transmitter KitMicron Medical Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑