FDA 510(k)

Choledochoscope System

N.º K: K231497 · 2024-03-06

SolicitanteShenzhen HugeMed Medical Technical Development Co., Ltd.

Fecha de decisión2024-03-06

Código de productoFBN

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Choledochoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K231497. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Choledochoscope System?

Choledochoscope System is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K231497.

When did Choledochoscope System receive FDA 510(k) clearance?

Choledochoscope System received FDA 510(k) clearance on 2024-03-06, under 510(k) number K231497.

Who is the listed applicant for Choledochoscope System?

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

What is the FDA product code for Choledochoscope System?

The FDA product code for Choledochoscope System is FBN.

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Otros registros que enlistan a Shenzhen HugeMed Medical Technical Development Co., Ltd. como solicitante

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Dispositivos relacionados (Código: FBN)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.