K250400
- 510(k) number
- K250400
- Device name
- Vigeon Laparoscopic Universal Smoke Evacuator (VG003)
- Applicant
- Vigeon Technology Co., Ltd. TW
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2025-05-09
- Date received
- 2025-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250400.pdf
Official FDA record: K250400
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.