# K260516: BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)

- Pathway: 510(k) (Traditional)
- Applicant: MacroLux Medical Technology Co., Ltd.
- Decided: Jul 20, 2026 after 153 days
- Product code: FGB (Ureteroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931154 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172098: Medical Video Endoscope System, Zhuhai Pusen Medical Technology Co., Ltd. (2017) Summary page 5.

## Indications for use
The BubbleView Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. The BubbleView is intended to provide visualization via ViewHub video processor and can be used with endoscopic accessories. BubbleView is intended for use in a hospital environment or medical office environment. BubbleView is designed for use in adults.

Source page: https://510kreport.com/device/K260516
Methodology: https://510kreport.com/methodology