# K143517: Voyant Open Sealer-Divider Device

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Mar 27, 2015 after 105 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K932293 (1994). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123444: Ligasure Impact Curved, Large Jaw, Open Sealer / Divider, Covidien, Formerly Valleylab, A Division of Tyco H (2013) Summary page 4.

## Most influential descendants
- K153288: Voyant Open Fusion Device (2016), 0 descendants of its own

## Recalls of this device
- Jul 31, 2015 · Class II · Z-2769-2015: Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.

## Indications for use
The Voyant Open Sealer/Divider device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation and division of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 5mm 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/K143517
Methodology: https://510kreport.com/methodology