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Voyant Fine Fusion

FDA 510(k)

Class II (US FDA 510(k))

510(k) K153017

by Applied Medical Resources

Identifiers

510(k) Number
K153017 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 Fine Fusion is a radiofrequency vessel sealing device (product code GEI) designed for open surgical procedures. It delivers controlled bipolar radiofrequency energy to seal vessels up to 7 mm in diameter and tissue bundles, creating a permanent, fused seal. The device features finer jaws compared to standard models, enabling precision in confined or delicate anatomical regions, including head and neck surgeries. Its design prioritises tissue differentiation and adaptive energy delivery for optimal sealing performance.

The Voyant Fine Fusion is supplied as a reusable surgical instrument, intended for use in sterile operating room environments. It requires no additional sterility beyond standard surgical instrument reprocessing protocols and is compatible with standard MRI safety guidelines for surgical tools. The device is authorised under FDA 510(k) clearance (K153017) as substantially equivalent to predicate devices in the General, Plastic Surgery advisory committee category. No third-party certification beyond regulatory submission is indicated in the specifications.

Frequently asked questions

What is the Voyant Fine Fusion used for in surgery?

The Voyant Fine Fusion is a radiofrequency vessel sealing device designed specifically for open surgical procedures. It delivers controlled bipolar radiofrequency energy to seal blood vessels up to 7 mm in diameter and tissue bundles, creating a permanent, fused seal. Its finer jaws compared to standard models allow for greater precision in confined or delicate anatomical regions, making it particularly useful in surgeries such as head and neck procedures where tissue differentiation and careful handling are critical.

Is the Voyant Fine Fusion a single-use or reusable device?

The Voyant Fine Fusion is a reusable surgical instrument. It is intended to be used in sterile operating room environments and follows standard surgical instrument reprocessing protocols to maintain sterility. This design choice ensures cost-effectiveness and reduces waste, as the device can be cleaned, sterilized, and reused for multiple procedures.

What size vessels can the Voyant Fine Fusion seal?

The Voyant Fine Fusion is capable of sealing blood vessels up to 7 mm in diameter. Its fine jaws and adaptive energy delivery system are optimized for precision, making it suitable for both larger vessels and delicate tissue bundles in confined anatomical areas. This range is particularly advantageous in surgeries requiring careful control over vessel sealing.

How does the Voyant Fine Fusion ensure safety in MRI environments?

The Voyant Fine Fusion is designed to be compatible with standard MRI safety guidelines for surgical tools. This means it can be safely used in operating rooms where MRI-compatible equipment is required, reducing the risk of interference or complications during imaging procedures. Always verify compatibility with your specific MRI system before use.

What regulatory clearance does the Voyant Fine Fusion hold?

The Voyant Fine Fusion holds FDA 510(k) clearance under the reference number K153017. It was determined to be substantially equivalent to predicate devices within the General, Plastic Surgery advisory committee category. This clearance indicates that the device meets the regulatory standards for safety and effectiveness as established by the FDA for its intended use.

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 Fine Fusion | Applied Medical, Voyant Intelligent Energy System - Applied Medical, Voyant System | 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) K153017 24 fields · synced Oct 1, 2026