FDA 510(k)

Disposable Endoscopic Bipolar

Número K: K231615 · 2023-12-05

RequerenteJiangsu Hope Biomedical Science & Technology Co., Ltd.

Data da decisão2023-12-05

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Endoscopic Bipolar is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Hope Biomedical Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-05 under 510(k) number K231615. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Endoscopic Bipolar?

Disposable Endoscopic Bipolar is a medical device that received FDA 510(k) clearance on 2023-12-05. The listed applicant is Jiangsu Hope Biomedical Science & Technology Co., Ltd.. The 510(k) number is K231615.

When did Disposable Endoscopic Bipolar receive FDA 510(k) clearance?

Disposable Endoscopic Bipolar received FDA 510(k) clearance on 2023-12-05, under 510(k) number K231615.

Who is the listed applicant for Disposable Endoscopic Bipolar?

The FDA 510(k) record lists Jiangsu Hope Biomedical Science & Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscopic Bipolar?

The FDA product code for Disposable Endoscopic Bipolar is GEI.

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