FDA 510(k)

AdvaTx

Número K: K250189 · 2025-04-01

Data da decisão2025-04-01

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

AdvaTx is the device name listed in this FDA 510(k) record. The listed applicant is Advalight Aps. It received FDA 510(k) clearance on 2025-04-01 under 510(k) number K250189. 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 AdvaTx?

AdvaTx is a medical device that received FDA 510(k) clearance on 2025-04-01. The listed applicant is Advalight Aps. The 510(k) number is K250189.

When did AdvaTx receive FDA 510(k) clearance?

AdvaTx received FDA 510(k) clearance on 2025-04-01, under 510(k) number K250189.

Who is the listed applicant for AdvaTx?

The FDA 510(k) record lists Advalight Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AdvaTx?

The FDA product code for AdvaTx is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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