FDA 510(k)

Disposable Cytology Brush (AF series)

Número K: K241679 · 2025-03-04

RequerenteAlton (Shanghai) Medical Instruments Co., Ltd.

Data da decisão2025-03-04

Código do produtoKTI

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Cytology Brush (AF series) is the device name listed in this FDA 510(k) record. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-03-04 under 510(k) number K241679. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Cytology Brush (AF series)?

Disposable Cytology Brush (AF series) is a medical device that received FDA 510(k) clearance on 2025-03-04. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K241679.

When did Disposable Cytology Brush (AF series) receive FDA 510(k) clearance?

Disposable Cytology Brush (AF series) received FDA 510(k) clearance on 2025-03-04, under 510(k) number K241679.

Who is the listed applicant for Disposable Cytology Brush (AF series)?

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

What is the FDA product code for Disposable Cytology Brush (AF series)?

The FDA product code for Disposable Cytology Brush (AF series) is KTI.

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Fonte oficial

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