FDA 510(k)

Endoscopic Injection Needle

Número K: K213239 · 2022-06-02

RequerenteBeijing Zksk Technology Co., Ltd.

Data da decisão2022-06-02

Código do produtoFBK

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Endoscopic Injection Needle is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Zksk Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K213239. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Endoscopic Injection Needle?

Endoscopic Injection Needle is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Beijing Zksk Technology Co., Ltd.. The 510(k) number is K213239.

When did Endoscopic Injection Needle receive FDA 510(k) clearance?

Endoscopic Injection Needle received FDA 510(k) clearance on 2022-06-02, under 510(k) number K213239.

Who is the listed applicant for Endoscopic Injection Needle?

The FDA 510(k) record lists Beijing Zksk Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endoscopic Injection Needle?

The FDA product code for Endoscopic Injection Needle is FBK.

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Fonte oficial

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