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FDA 510(k)

Vesalio Peripheral System

K-Number: K251312 · 2025-10-24

ApplicantVesalio, Inc.
Decision Date2025-10-24
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vesalio Peripheral System is a medical device manufactured by Vesalio, Inc.. It received FDA 510(k) clearance on 2025-10-24 under approval number K251312. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vesalio Peripheral System?

Vesalio Peripheral System is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Vesalio, Inc.. The 510(k) number is K251312.

When was Vesalio Peripheral System approved by the FDA?

Vesalio Peripheral System received FDA 510(k) clearance on 2025-10-24, under approval number K251312.

What company makes Vesalio Peripheral System?

Vesalio Peripheral System is manufactured by Vesalio, Inc..

What is the FDA product code for Vesalio Peripheral System?

The FDA product code for Vesalio Peripheral System is QEZ.

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Related PubMed Literature

PMID: 38815918 What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices. Annals of vascular surgery (2024) PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 31472187 A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic. Journal of neuroscience methods (2019) PMID: 29988408 Regulation of Neurological Devices and Neurointerventional Endovascular Approaches for Acute Ischemic Stroke. Frontiers in neurology (2018)

Other Devices by Vesalio, Inc.

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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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