FDA 510(k)

TissueTak device

Número K: K203117 · 2021-01-07

Data da decisão2021-01-07

Código do produtoGDW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

TissueTak device is the device name listed in this FDA 510(k) record. The listed applicant is Via Surgical , Ltd.. It received FDA 510(k) clearance on 2021-01-07 under 510(k) number K203117. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TissueTak device?

TissueTak device is a medical device that received FDA 510(k) clearance on 2021-01-07. The listed applicant is Via Surgical , Ltd.. The 510(k) number is K203117.

When did TissueTak device receive FDA 510(k) clearance?

TissueTak device received FDA 510(k) clearance on 2021-01-07, under 510(k) number K203117.

Who is the listed applicant for TissueTak device?

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

What is the FDA product code for TissueTak device?

The FDA product code for TissueTak device is GDW.

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Dispositivos Relacionados (Código: GDW)

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