FDA 510(k)

Disposable Automatic Core Biopsy Instrument

N.º K: K212284 · 2021-11-10

SolicitanteSuzhou Leapmed Healthcare Corporation

Fecha de decisión2021-11-10

Código de productoKNW

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Suzhou Leapmed Healthcare Corporation como solicitante

K212819Disposable Biopsy Refill Needle K212820Disposable Semi Automatic Biopsy Instrument K212822Disposable Coaxial Biopsy Needle

Dispositivos relacionados (Código: KNW)

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Fuente oficial

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