FDA 510(k)

Pen Needle

Número K: K230635 · 2023-06-02

Data da decisão2023-06-02

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K230635. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pen Needle?

Pen Needle is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K230635.

When did Pen Needle receive FDA 510(k) clearance?

Pen Needle received FDA 510(k) clearance on 2023-06-02, under 510(k) number K230635.

Who is the listed applicant for Pen Needle?

The FDA 510(k) record lists Jiangsu Caina Medical Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pen Needle?

The FDA product code for Pen Needle is FMI.

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Dispositivos Relacionados (Código: FMI)

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Fonte oficial

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