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FDA 510(k)

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem

Número K: K161409 · 2016-08-02

RequerenteMermaid Medical A/S
Data da decisão2016-08-02
Código do produtoKNW
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem is the device name listed in this FDA 510(k) record. The listed applicant is Mermaid Medical A/S. It received FDA 510(k) clearance on 2016-08-02 under 510(k) number K161409. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem?

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem is a medical device that received FDA 510(k) clearance on 2016-08-02. The listed applicant is Mermaid Medical A/S. The 510(k) number is K161409.

When did M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem receive FDA 510(k) clearance?

M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem received FDA 510(k) clearance on 2016-08-02, under 510(k) number K161409.

Who is the listed applicant for M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem?

The FDA 510(k) record lists Mermaid Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem?

The FDA product code for M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem is KNW.

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Dispositivos Relacionados (Código: KNW)

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