Manufacturer
Vigeon Technology Co., Ltd.Vigeon Laparoscopic Universal Smoke Evacuator (VG003)
Country / Region:Taiwan (TW)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250400
- Device name
- Vigeon Laparoscopic Universal Smoke Evacuator (VG003)
- Company
- Vigeon Technology Co., Ltd.
- Country / Region
- Taiwan(TW)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-02-12
- Decision date
- 2025-05-09
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgery
- Primary application
- Surgery
- Classification source
- AI classified
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.
Intended 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.
Device Description
The smoke evacuator has two parts - the exhaust tube and the control valve. The product can be installed on 5mm surgical electrode/high-energy instrument in minimally invasive surgery. The product is connected with the vacuum suction system, using negative pressure to extract smoke, small amount of blood and water from the tip of the surgical instrument. The product design may improve the visibility of visual field and patient safety during surgery.
Summary parsed at:2026-06-20 17:47:59 UTC