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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 a medical device manufactured by Bioness, Inc.. It received FDA 510(k) clearance on 2022-02-23 under approval 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. It is manufactured by Bioness, Inc.. The 510(k) number is K211965.

When was StimRouter Neuromodulation System approved by the FDA?

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

What company makes StimRouter Neuromodulation System?

StimRouter Neuromodulation System is manufactured by Bioness, Inc..

What is the FDA product code for StimRouter Neuromodulation System?

The FDA product code for StimRouter Neuromodulation System is GZF.

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Other Devices by Bioness, Inc.

K162407L300 Go System K173682L300 Go System K190047StimRouter Neuromodulation System K191587L360 Thigh System K190285L300 Go System K200482StimRouter Neuromodulation System

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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.

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