FDA 510(k)

Stardust Med

Número K: K200736 · 2020-06-26

Data da decisão2020-06-26

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Stardust Med is the device name listed in this FDA 510(k) record. The listed applicant is I.T.S. Group S.R.L.. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K200736. 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 Stardust Med?

Stardust Med is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is I.T.S. Group S.R.L.. The 510(k) number is K200736.

When did Stardust Med receive FDA 510(k) clearance?

Stardust Med received FDA 510(k) clearance on 2020-06-26, under 510(k) number K200736.

Who is the listed applicant for Stardust Med?

The FDA 510(k) record lists I.T.S. Group S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stardust Med?

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

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