# K252412: Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corporation
- Decided: Oct 31, 2025 after 91 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 K911904 (1991). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151649: Valleylab FT10 Electrosurgical Platform, Covidien (2015) Summary page 5.
- K182244: Voyant Electrosurgical Generator, Applied Medical Resources Corp. (2018) Summary page 5.

## Indications for use
Advanced Bipolar: The Voyant electrosurgical generator is indicated for use with advanced bipolar Voyant devices in open and minimally invasive procedures where the ligation of vessels up to and including 7mm in diameter and tissue bundles is desired. NOTE: For indications specific to each Voyant device used with the Voyant generator, refer to each device's Instructions for Use (IFU). Monopolar/Bipolar: Intended to provide energy to standard monopolar and bipolar surgical accessories.

Source page: https://510kreport.com/device/K252412
Methodology: https://510kreport.com/methodology