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FDA 510(k)

StimRouter Neuromodulation System

K-Number: K211965 · 2022-02-23

ApplicantBioness, Inc.
Decision Date2022-02-23
Product CodeGZF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StimRouter Neuromodulation System is the device name listed in this FDA 510(k) record. The listed applicant is Bioness, Inc.. It received FDA 510(k) clearance on 2022-02-23 under 510(k) number K211965. 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 StimRouter Neuromodulation System?

StimRouter Neuromodulation System is a medical device that received FDA 510(k) clearance on 2022-02-23. The listed applicant is Bioness, Inc.. The 510(k) number is K211965.

When did StimRouter Neuromodulation System receive FDA 510(k) clearance?

StimRouter Neuromodulation System received FDA 510(k) clearance on 2022-02-23, under 510(k) number K211965.

Who is the listed applicant for StimRouter Neuromodulation System?

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

What is the FDA product code for StimRouter Neuromodulation System?

The FDA product code for StimRouter Neuromodulation System is GZF.

Other records listing Bioness, 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.

K200482StimRouter Neuromodulation SystemK200262L100 Go SystemK190047StimRouter Neuromodulation SystemK191587L360 Thigh SystemK190285L300 Go SystemK173682L300 Go System

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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.K202781Neuspera Neurostimulation System (NNS)Neuspera Medical, 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.

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