# K243155: Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Zsr Biomedical Technology Company Limited
- Decided: Feb 11, 2025 after 134 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: 10 generations back to K931154 (1993). 26 ancestors in all.
No later device cites it as a predicate yet.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230200: Single-Use Flexible Ureteroscope, Hunan Vathin Medical Instrument Co., Ltd. (2023) Summary page 5.

## Indications for use
Single-Use Digital Flexible Ureteroscope (F-URS)(ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)： This product is used in medical institutions, in conjunction with our electronic endoscope image processor, for imaging in examination, diagnosis or treatment of urinary system diseases. Endoscope Imaging Processor (ZSR-EOS10)： Applicable to medical institutions, which are connected with electronic endoscopes during endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors.

Source page: https://510kreport.com/device/K243155
Methodology: https://510kreport.com/methodology