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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 the device name listed in this FDA 510(k) record. The listed applicant is Vigeon Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-09 under 510(k) 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. The listed applicant is Vigeon Technology Co., Ltd.. The 510(k) number is K250400.

When did Vigeon Laparoscopic Universal Smoke Evacuator (VG003) receive FDA 510(k) clearance?

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

Who is the listed applicant for Vigeon Laparoscopic Universal Smoke Evacuator (VG003)?

The FDA 510(k) record lists Vigeon Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Official Source

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

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