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Voyant Open Fusion Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162676

by Applied Medical Resources

Identifiers

510(k) Number
K162676 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Voyant Open Fusion Device is a surgical instrument designed to seal vessels and tissue bundles in open procedures. It delivers radio-frequency energy to tissue captured between its jaws and divides sealed tissue with a user-actuated blade. The device is intended for use in procedures requiring larger jaws and effectively seals vessels up to and including 7mm in diameter.

The device is supplied non-sterile and is intended for single use. It is used in open surgical settings and has received FDA 510(k) clearance under product code GEI. The Voyant Open Fusion Device is manufactured by Applied Medical Resources and was cleared via traditional 510(k) submission K162676 on December 1, 2016.

Frequently asked questions

What is the Voyant Open Fusion Device used for?

The Voyant Open Fusion Device is designed to seal vessels and tissue bundles in open surgical procedures. It delivers radio-frequency energy to tissue captured between its jaws and divides sealed tissue with a user-actuated blade, making it suitable for procedures requiring larger jaws and effective sealing of vessels up to and including 7mm in diameter.

How is the Voyant Open Fusion Device supplied and is it reusable?

The device is supplied non-sterile and is intended for single use only. It should not be reprocessed or reused, as it is designed for one-time application in open surgical settings to ensure patient safety and device performance.

What regulatory pathway was used for the Voyant Open Fusion Device?

The Voyant Open Fusion Device received FDA 510(k) clearance via a traditional submission under product code GEI. It was found substantially equivalent to a predicate device and cleared on December 1, 2016, under k-number K162676.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Voyant Open Fusion | Applied Medical, Voyant Intelligent Energy System - Applied Medical, Voyant Fine Fusion | Applied Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Applied Medical Resources

Sources (1)

  • FDA 510(k) K162676 24 fields · synced Sep 21, 2026