# K250400: Vigeon Laparoscopic Universal Smoke Evacuator (VG003)

- Pathway: 510(k) (Traditional)
- Applicant: Vigeon Technology Co., Ltd.
- Decided: May 9, 2025 after 86 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: 3 generations back to K936304 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160128: Endopath Electrosurgery Probe Plus II, Ethicon Endo-Surgery, LLC (2016) Summary page 5.
- K213317: ShinEvac Smoke Evacuation Pencil, Shining World Health Care Co., Ltd. (2022) Summary page 5.

## Indications for use
This product is indicated for use in minimally invasive procedures for removing smoke generated by electrocautery and small amount of fluids when used in conjunction with an effective suction equipment.

Source page: https://510kreport.com/device/K250400
Methodology: https://510kreport.com/methodology