FDA 510(k)

Siberian Fit

Número K: K172439 · 2018-02-14

Data da decisão2018-02-14

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Siberian Fit is the device name listed in this FDA 510(k) record. The listed applicant is Vydence. It received FDA 510(k) clearance on 2018-02-14 under 510(k) number K172439. 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 Siberian Fit?

Siberian Fit is a medical device that received FDA 510(k) clearance on 2018-02-14. The listed applicant is Vydence. The 510(k) number is K172439.

When did Siberian Fit receive FDA 510(k) clearance?

Siberian Fit received FDA 510(k) clearance on 2018-02-14, under 510(k) number K172439.

Who is the listed applicant for Siberian Fit?

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

What is the FDA product code for Siberian Fit?

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

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