FDA 510(k)

Automatic Core Biopsy Instrument

Número K: K260517 · 2026-08-28

RequerenteZhejiang Curaway Medical Technology Co., Ltd.

Data da decisão2026-08-28

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Automatic Core Biopsy Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-08-28 under 510(k) number K260517. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Automatic Core Biopsy Instrument?

Automatic Core Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2026-08-28. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K260517.

When did Automatic Core Biopsy Instrument receive FDA 510(k) clearance?

Automatic Core Biopsy Instrument received FDA 510(k) clearance on 2026-08-28, under 510(k) number K260517.

Who is the listed applicant for Automatic Core Biopsy Instrument?

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

What is the FDA product code for Automatic Core Biopsy Instrument?

The FDA product code for Automatic Core Biopsy Instrument is KNW.

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