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510(k) Data Aggregation
K Number
K250400Device Name
Vigeon Laparoscopic Universal Smoke Evacuator (VG003)
Manufacturer
Date Cleared
2025-05-09
(86 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Vigeon Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
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