FDA 510(k)

Deflectable Brush Biopsy Set

Número K: K191485 · 2019-06-26

Data da decisão2019-06-26

Código do produtoFDX

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Deflectable Brush Biopsy Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-06-26 under 510(k) number K191485. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Deflectable Brush Biopsy Set?

Deflectable Brush Biopsy Set is a medical device that received FDA 510(k) clearance on 2019-06-26. The listed applicant is Cook Incorporated. The 510(k) number is K191485.

When did Deflectable Brush Biopsy Set receive FDA 510(k) clearance?

Deflectable Brush Biopsy Set received FDA 510(k) clearance on 2019-06-26, under 510(k) number K191485.

Who is the listed applicant for Deflectable Brush Biopsy Set?

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

What is the FDA product code for Deflectable Brush Biopsy Set?

The FDA product code for Deflectable Brush Biopsy Set is FDX.

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Dispositivos Relacionados (Código: FDX)

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