FDA 510(k)

Archworx

Número K: K173738 · 2021-02-26

RequerenteUtah Medical Products and Services

Data da decisão2021-02-26

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Archworx is the device name listed in this FDA 510(k) record. The listed applicant is Utah Medical Products and Services. It received FDA 510(k) clearance on 2021-02-26 under 510(k) number K173738. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Archworx?

Archworx is a medical device that received FDA 510(k) clearance on 2021-02-26. The listed applicant is Utah Medical Products and Services. The 510(k) number is K173738.

When did Archworx receive FDA 510(k) clearance?

Archworx received FDA 510(k) clearance on 2021-02-26, under 510(k) number K173738.

Who is the listed applicant for Archworx?

The FDA 510(k) record lists Utah Medical Products and Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Archworx?

The FDA product code for Archworx is NXC.

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