FDA · official record K260516Substantially Equivalent

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

Name: BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) — FDA K260516
Creator: MacroLux Medical Technology Co., Ltd.
Keywords: 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), K260516, FGB, FDA

United StatesFGBMacroLux Medical Technology Co., Ltd.

Verified

Official record identity

FDA application number: K260516
Decision date: July 20, 2026
Published decision: Substantially Equivalent

Classification

Product code: FGB

Published parties

Applicant: MacroLux Medical Technology Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2026-02-17
Review panel: Gastroenterology, Urology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 876.1500

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.