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)

StimRouter Neuromodulation System

K-Number: K200482 · 2020-03-27

ApplicantBioness, Inc.
Decision Date2020-03-27
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 2020-03-27 under approval number K200482. 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 2020-03-27. It is manufactured by Bioness, Inc.. The 510(k) number is K200482.

When was StimRouter Neuromodulation System approved by the FDA?

StimRouter Neuromodulation System received FDA 510(k) clearance on 2020-03-27, under approval number K200482.

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.

Related Clinical Trials

NCT07193407 INOPASE - Performance and Safety Study of a Personalised SNM System RECRUITING NCT06885931 Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications) RECRUITING NCT06511141 Sacral Neuromodulation for Male Overactive Bladder (MOAB) RECRUITING NCT07577102 Unilateral and Bilateral taVNS in Fibromyalgia COMPLETED NCT03819608 Neuromodulation and Neurorehabilitation for mTBI RECRUITING NCT06434831 Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation RECRUITING

Other Devices by Bioness, Inc.

K162407L300 Go System K173682L300 Go System K190047StimRouter Neuromodulation System K191587L360 Thigh System K190285L300 Go System K200262L100 Go System

View all 8 devices →

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.

↑