FDA 510(k)

Disposable Biopsy Refill Needle

Número K: K212819 · 2022-07-06

RequerenteSuzhou Leapmed Healthcare Corporation

Data da decisão2022-07-06

Código do produtoFCG

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Biopsy Refill Needle 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 2022-07-06 under 510(k) number K212819. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Biopsy Refill Needle?

Disposable Biopsy Refill Needle is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is Suzhou Leapmed Healthcare Corporation. The 510(k) number is K212819.

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

Disposable Biopsy Refill Needle received FDA 510(k) clearance on 2022-07-06, under 510(k) number K212819.

Who is the listed applicant for Disposable Biopsy Refill Needle?

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 Biopsy Refill Needle?

The FDA product code for Disposable Biopsy Refill Needle is FCG.

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Outros registros que listam Suzhou Leapmed Healthcare Corporation como candidato(a)

K212820Disposable Semi Automatic Biopsy Instrument K212822Disposable Coaxial Biopsy Needle K212284Disposable Automatic Core Biopsy Instrument

Dispositivos Relacionados (Código: FCG)

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

Fonte oficial

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