Voyant Maryland Fusion Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182653 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 Maryland Fusion Device is a surgical instrument designed to seal vessels and tissue bundles using radio-frequency energy. It delivers energy to tissue captured between its jaws and divides sealed tissue with a user-actuated blade.
The device is intended for use in laparoscopic and open procedures, and is designed for use with 5mm-or-larger trocars in laparoscopic applications. It is supplied as a single-use device and has received FDA 510(k) clearance under product code GEI.
Frequently asked questions
What is the Voyant Maryland Fusion Device used for?
The Voyant Maryland Fusion Device is designed to seal vessels and tissue bundles using radio-frequency energy delivered between its jaws, and it divides the sealed tissue with a user-actuated blade during surgical procedures.
How is the Voyant Maryland Fusion Device supplied and is it reusable?
The device is supplied as a single-use instrument, meaning it is intended for one procedure only and should not be reprocessed or reused to ensure patient safety and device performance.
What types of surgical procedures is the Voyant Maryland Fusion Device intended for?
The device is intended for use in both laparoscopic and open surgical procedures, and it is designed to work with 5mm-or-larger trocars in laparoscopic applications.
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 Maryland Fusion | Applied Medical, Voyant Intelligent Energy System - Applied Medical, Voyant Maryland Fusion Device - Medical XPRT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182653 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA 510(k) K182653 24 fields · synced Oct 1, 2026