FDA 510(k)

Vigeon Laparoscopic Universal Smoke Evacuator (VG003)

Número K: K250400 · 2025-05-09

Data da decisão2025-05-09

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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Fonte oficial

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