FDA 510(k)

BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)

Número K: K260516 · 2026-07-20

RequerenteMacroLux Medical Technology Co., Ltd.

Data da decisão2026-07-20

Código do produtoFGB

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) is the device name listed in this FDA 510(k) record. The listed applicant is MacroLux Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-07-20 under 510(k) number K260516. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)?

BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) is a medical device that received FDA 510(k) clearance on 2026-07-20. The listed applicant is MacroLux Medical Technology Co., Ltd.. The 510(k) number is K260516.

When did BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) receive FDA 510(k) clearance?

BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) received FDA 510(k) clearance on 2026-07-20, under 510(k) number K260516.

Who is the listed applicant for BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)?

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

Qual é o código de produto da FDA para o Cystoscope Digital Flexível de Uso Único BubbleView (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)?

The FDA product code for BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) is FGB.

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

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