FDA 510(k)

Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)

Número K: K172344 · 2017-11-13

Data da decisão2017-11-13

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) is the device name listed in this FDA 510(k) record. The listed applicant is Medax Srl Unipersonale. It received FDA 510(k) clearance on 2017-11-13 under 510(k) number K172344. 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 Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)?

Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) is a medical device that received FDA 510(k) clearance on 2017-11-13. The listed applicant is Medax Srl Unipersonale. The 510(k) number is K172344.

When did Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) receive FDA 510(k) clearance?

Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) received FDA 510(k) clearance on 2017-11-13, under 510(k) number K172344.

Who is the listed applicant for Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)?

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

What is the FDA product code for Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)?

The FDA product code for Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) is KNW.

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Outros registros que listam Medax Srl Unipersonale como candidato(a)

K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System K192101Medone Ultra, Medextra K181803Medax Biopsy Systems III

Dispositivos Relacionados (Código: KNW)

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