# K193292: Voyant 5mm Fusion Device, Voyant Maryland Fusion Device

- Pathway: 510(k) (Special)
- Applicant: Applied Medical Resources Corp.
- Decided: Dec 20, 2019 after 23 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K932293 (1994). 15 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141288: Voyant Electrosurgical Generator, Voyant 5MM Laparoscopic Sealer-Divider Device, Applied Medical Resources (2014) Summary page 4.
- K172624: Voyant 5mm Fusion Device, Applied Medical Resources Corporation (2018) Summary page 4.
- K182653: Voyant Maryland Fusion Device, Applied Medical Resources Corp. (2018) Summary page 4.

## Most influential descendants
- K201212: Voyant Open Fusion Device (2020), 1 descendant of its own
- K200598: Voyant Maryland Fusion Device (2020), 1 descendant of its own
- K252740: Voyant® Open Fusion Device (EB240/Open Fusion) (2025), 0 descendants of its own
- K222284: Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) (2022), 0 descendants of its own

## Indications for use
The Voyant [5mm/Maryland] Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation and division of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Source page: https://510kreport.com/device/K193292
Methodology: https://510kreport.com/methodology