FDA 510(k)

Tamburo Thulium Fiber Laser System

Número K: K251303 · 2025-11-04

RequerenteMenovex Medical Technology (Shenzhen) Co., Ltd.

Data da decisão2025-11-04

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tamburo Thulium Fiber Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Menovex Medical Technology (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2025-11-04 under 510(k) number K251303. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tamburo Thulium Fiber Laser System?

Tamburo Thulium Fiber Laser System is a medical device that received FDA 510(k) clearance on 2025-11-04. The listed applicant is Menovex Medical Technology (Shenzhen) Co., Ltd.. The 510(k) number is K251303.

When did Tamburo Thulium Fiber Laser System receive FDA 510(k) clearance?

Tamburo Thulium Fiber Laser System received FDA 510(k) clearance on 2025-11-04, under 510(k) number K251303.

Who is the listed applicant for Tamburo Thulium Fiber Laser System?

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

What is the FDA product code for Tamburo Thulium Fiber Laser System?

The FDA product code for Tamburo Thulium Fiber Laser System is GEX. This falls under the Gastroenterology category.

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