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FDA 510(k)

StimTrial Neuromodulation System

K-Number: K243782 · 2025-07-16

ApplicantBioventus, LLC
Decision Date2025-07-16
Product CodeGZF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StimTrial Neuromodulation System is a medical device manufactured by Bioventus, LLC. It received FDA 510(k) clearance on 2025-07-16 under approval number K243782. 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 StimTrial Neuromodulation System?

StimTrial Neuromodulation System is a medical device that received FDA 510(k) clearance on 2025-07-16. It is manufactured by Bioventus, LLC. The 510(k) number is K243782.

When was StimTrial Neuromodulation System approved by the FDA?

StimTrial Neuromodulation System received FDA 510(k) clearance on 2025-07-16, under approval number K243782.

What company makes StimTrial Neuromodulation System?

StimTrial Neuromodulation System is manufactured by Bioventus, LLC.

What is the FDA product code for StimTrial Neuromodulation System?

The FDA product code for StimTrial Neuromodulation System is GZF.

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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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