Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Neuspera Medical, Inc.. It received FDA 510(k) clearance on 2021-08-27 under 510(k) 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. The listed applicant is Neuspera Medical, Inc.. The 510(k) number is K202781.

When did Neuspera Neurostimulation System (NNS) receive FDA 510(k) clearance?

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

Who is the listed applicant for Neuspera Neurostimulation System (NNS)?

The FDA 510(k) record lists Neuspera Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Neuspera Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P240031Stimulator, electrical, implantable, for incontinenceK221303Neuspera Nuity System

Related Devices (Code: GZF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243782StimTrial Neuromodulation SystemBioventus, LLCK243678TalisMann Neuromodulation SystemBioventus, LLCK232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific NeuromodulationK233162Freedom Peripheral Nerve Stimulator (PNS) SystemCuronixK221303Neuspera Nuity SystemNeuspera Medical, Inc.K211965StimRouter Neuromodulation SystemBioness, Inc.

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.

↑