FDA 510(k)

HTx Disposable Hysteroscope System

N.º K: K231260 · 2024-03-05

SolicitanteSuzhou AcuVu Medical Technology Co., Ltd.

Fecha de decisión2024-03-05

Código de productoHIH

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

HTx Disposable Hysteroscope System is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou AcuVu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-03-05 under 510(k) number K231260. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HTx Disposable Hysteroscope System?

HTx Disposable Hysteroscope System is a medical device that received FDA 510(k) clearance on 2024-03-05. The listed applicant is Suzhou AcuVu Medical Technology Co., Ltd.. The 510(k) number is K231260.

When did HTx Disposable Hysteroscope System receive FDA 510(k) clearance?

HTx Disposable Hysteroscope System received FDA 510(k) clearance on 2024-03-05, under 510(k) number K231260.

Who is the listed applicant for HTx Disposable Hysteroscope System?

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

What is the FDA product code for HTx Disposable Hysteroscope System?

The FDA product code for HTx Disposable Hysteroscope System is HIH.

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Otros registros que enlistan a Suzhou AcuVu Medical Technology Co., Ltd. como solicitante

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Dispositivos relacionados (Código: HIH)

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Fuente oficial

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