FDA 510(k)

Patriot Duo

Número K: K251824 · 2025-10-27

Data da decisão2025-10-27

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Patriot Duo is the device name listed in this FDA 510(k) record. The listed applicant is Patriot Laser, LLC. It received FDA 510(k) clearance on 2025-10-27 under 510(k) number K251824. 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 Patriot Duo?

Patriot Duo is a medical device that received FDA 510(k) clearance on 2025-10-27. The listed applicant is Patriot Laser, LLC. The 510(k) number is K251824.

When did Patriot Duo receive FDA 510(k) clearance?

Patriot Duo received FDA 510(k) clearance on 2025-10-27, under 510(k) number K251824.

Who is the listed applicant for Patriot Duo?

The FDA 510(k) record lists Patriot Laser, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Patriot Duo?

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

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