FDA 510(k)

4K UHD Laparoscope

Número K: K203255 · 2021-02-24

RequerenteScivita Medical Technology Co., Ltd.

Data da decisão2021-02-24

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

4K UHD Laparoscope is the device name listed in this FDA 510(k) record. The listed applicant is Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-24 under 510(k) number K203255. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 4K UHD Laparoscope?

4K UHD Laparoscope is a medical device that received FDA 510(k) clearance on 2021-02-24. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K203255.

When did 4K UHD Laparoscope receive FDA 510(k) clearance?

4K UHD Laparoscope received FDA 510(k) clearance on 2021-02-24, under 510(k) number K203255.

Who is the listed applicant for 4K UHD Laparoscope?

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

What is the FDA product code for 4K UHD Laparoscope?

The FDA product code for 4K UHD Laparoscope is GCJ.

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Outros registros que listam Scivita Medical Technology Co., Ltd. como candidato(a)

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