FDA 510(k)

Automatic Core Biopsy Instrument

N.º K: K260517 · 2026-08-28

SolicitanteZhejiang Curaway Medical Technology Co., Ltd.

Fecha de decisión2026-08-28

Código de productoKNW

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Zhejiang Curaway Medical Technology Co., Ltd. como solicitante

K244018Disposable Biopsy Needle K242322Bone Marrow Biopsy Needle K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle K240758Radiofrequency Generator System, Cura RF Electrode K232505Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

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Dispositivos relacionados (Código: KNW)

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Fuente oficial

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