Voyant Open Fusion Device (EB240/Open Fusion)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252740 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 (EB240/Open Fusion) is a bipolar electrosurgical device designed for open surgical procedures. It is classified as a Vessel Ligation Device (product code: GEI) and delivers radio-frequency energy to seal vessels and tissue bundles up to 7mm in diameter. The device incorporates a user-actuated blade to divide sealed tissue after ligation, facilitating precise and controlled tissue management during surgery.
This device is intended for use with the Voyant electrosurgical generator in open surgical settings. It is supplied as a reusable medical device and has received FDA 510(k) clearance under Special Review (K252740). The device is not indicated for MRI use and must be handled according to standard surgical instrument protocols. No sterility claims or single-use specifications are provided in the regulatory data.
Frequently asked questions
What is the Voyant Open Fusion Device (EB240/Open Fusion) used for?
The Voyant Open Fusion Device (EB240/Open Fusion) is designed for open surgical procedures to seal vessels and tissue bundles up to 7 millimeters in diameter. It uses radio-frequency energy to create a controlled ligation, followed by a user-actuated blade to divide the sealed tissue. This dual-action approach helps surgeons achieve precise and controlled tissue management during open surgeries.
How is the Voyant Open Fusion Device (EB240/Open Fusion) supplied and intended for use?
The Voyant Open Fusion Device (EB240/Open Fusion) is supplied as a reusable medical device. It is intended for use exclusively with the Voyant electrosurgical generator in open surgical settings. The device is not intended for MRI environments and must be handled according to standard surgical instrument protocols.
Is the Voyant Open Fusion Device (EB240/Open Fusion) single-use or reusable?
The Voyant Open Fusion Device (EB240/Open Fusion) is explicitly described as a reusable medical device. There are no claims of sterility or single-use specifications provided in the regulatory data, so it must be processed and maintained according to standard surgical instrument reprocessing guidelines.
What are the maximum vessel sizes this device can seal?
The Voyant Open Fusion Device (EB240/Open Fusion) is capable of sealing vessels and tissue bundles up to 7 millimeters in diameter. This specification is critical for ensuring the device’s suitability for specific surgical applications where precise control over vessel size is required.
What regulatory clearance does the Voyant Open Fusion Device (EB240/Open Fusion) have?
The Voyant Open Fusion Device (EB240/Open Fusion) has received FDA 510(k) clearance under Special Review (K252740). This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and is approved for use in open surgical procedures as described.
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® Open Fusion Device (EB240/Open Fusion) (K252740) — FDA 510 (k ..., K252740 - Voyant® Open Fusion Device (EB240/Open Fusion), Voyant Open Fusion Device | Medical Device Navigator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252740 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA 510(k) K252740 24 fields · synced Oct 1, 2026