FDA 510(k)

Disposable Endoscopic Bipolar

N.º K: K231615 · 2023-12-05

SolicitanteJiangsu Hope Biomedical Science & Technology Co., Ltd.

Fecha de decisión2023-12-05

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Jiangsu Hope Biomedical Science & Technology Co., Ltd. como solicitante

K232703Disposable Bipolar Forceps

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Fuente oficial

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