Voyant Fine Fusion Device EB230

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K202818 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the primary clinical use of the Voyant Fine Fusion Device?

  The Voyant Fine Fusion Device is designed for use in open surgical procedures to seal vessels up to 7mm in diameter and tissue bundles. Its finer jaw design makes it particularly suitable for head and neck surgeries where the surgical working space is limited.

• How does the device function during surgery?

  The instrument delivers radio-frequency energy to tissue captured between its jaws to create a seal. Once the seal is established, the device features a user-actuated blade that allows the surgeon to divide the sealed tissue.

• What is the regulatory status of the Voyant Fine Fusion Device?

  The Voyant Fine Fusion Device (EB230) has received FDA 510k clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.