FDA 510(k)

Disposable Biopsy Needle

Número K: K243296 · 2025-07-11

RequerenteCarbon (Shenzhen) Medical Device Co., Ltd.

Data da decisão2025-07-11

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Carbon (Shenzhen) Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2025-07-11 under 510(k) number K243296. 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 Disposable Biopsy Needle?

Disposable Biopsy Needle is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Carbon (Shenzhen) Medical Device Co., Ltd.. The 510(k) number is K243296.

When did Disposable Biopsy Needle receive FDA 510(k) clearance?

Disposable Biopsy Needle received FDA 510(k) clearance on 2025-07-11, under 510(k) number K243296.

Who is the listed applicant for Disposable Biopsy Needle?

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

What is the FDA product code for Disposable Biopsy Needle?

The FDA product code for Disposable Biopsy Needle is KNW.

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Outros registros que listam Carbon (Shenzhen) Medical Device Co., Ltd. como candidato(a)

K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System

Dispositivos Relacionados (Código: KNW)

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Fonte oficial

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