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FDA 510(k)

Vigeon Laparoscopic Universal Smoke Evacuator (VG003)

K-Number: K250400 · 2025-05-09

ApplicantVigeon Technology Co., Ltd.
Decision Date2025-05-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Vigeon Laparoscopic Universal Smoke Evacuator (VG003) is a medical device manufactured by Vigeon Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-09 under approval number K250400. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vigeon Laparoscopic Universal Smoke Evacuator (VG003)?

Vigeon Laparoscopic Universal Smoke Evacuator (VG003) is a medical device that received FDA 510(k) clearance on 2025-05-09. It is manufactured by Vigeon Technology Co., Ltd.. The 510(k) number is K250400.

When was Vigeon Laparoscopic Universal Smoke Evacuator (VG003) approved by the FDA?

Vigeon Laparoscopic Universal Smoke Evacuator (VG003) received FDA 510(k) clearance on 2025-05-09, under approval number K250400.

What company makes Vigeon Laparoscopic Universal Smoke Evacuator (VG003)?

Vigeon Laparoscopic Universal Smoke Evacuator (VG003) is manufactured by Vigeon Technology Co., Ltd..

What is the FDA product code for Vigeon Laparoscopic Universal Smoke Evacuator (VG003)?

The FDA product code for Vigeon Laparoscopic Universal Smoke Evacuator (VG003) is GEI.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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