FDA 510(k)

Medone Ultra, Medextra

Número K: K192101 · 2020-04-02

Data da decisão2020-04-02

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medone Ultra, Medextra 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 2020-04-02 under 510(k) number K192101. 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 Medone Ultra, Medextra?

Medone Ultra, Medextra is a medical device that received FDA 510(k) clearance on 2020-04-02. The listed applicant is Medax Srl Unipersonale. The 510(k) number is K192101.

When did Medone Ultra, Medextra receive FDA 510(k) clearance?

Medone Ultra, Medextra received FDA 510(k) clearance on 2020-04-02, under 510(k) number K192101.

Who is the listed applicant for Medone Ultra, Medextra?

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 Medone Ultra, Medextra?

The FDA product code for Medone Ultra, Medextra 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 K181803Medax Biopsy Systems III K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)

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Fonte oficial

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