FDA 510(k)

Disposable Automatic Core Biopsy Instrument

Número K: K212284 · 2021-11-10

RequerenteSuzhou Leapmed Healthcare Corporation

Data da decisão2021-11-10

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Automatic Core Biopsy Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Leapmed Healthcare Corporation. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K212284. 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 Automatic Core Biopsy Instrument?

Disposable Automatic Core Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Suzhou Leapmed Healthcare Corporation. The 510(k) number is K212284.

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

Disposable Automatic Core Biopsy Instrument received FDA 510(k) clearance on 2021-11-10, under 510(k) number K212284.

Who is the listed applicant for Disposable Automatic Core Biopsy Instrument?

The FDA 510(k) record lists Suzhou Leapmed Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

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