FDA 510(k)

Titan SGS

Número K: K210278 · 2021-04-28

Data da decisão2021-04-28

Código do produtoGDW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Titan SGS is the device name listed in this FDA 510(k) record. The listed applicant is Standard Bariatrics. It received FDA 510(k) clearance on 2021-04-28 under 510(k) number K210278. 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 Titan SGS?

Titan SGS is a medical device that received FDA 510(k) clearance on 2021-04-28. The listed applicant is Standard Bariatrics. The 510(k) number is K210278.

When did Titan SGS receive FDA 510(k) clearance?

Titan SGS received FDA 510(k) clearance on 2021-04-28, under 510(k) number K210278.

Who is the listed applicant for Titan SGS?

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

What is the FDA product code for Titan SGS?

The FDA product code for Titan SGS is GDW.

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Outros registros que listam Standard Bariatrics como candidato(a)

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Dispositivos Relacionados (Código: GDW)

Fonte oficial

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