# K252176: Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

- Pathway: 510(k) (Special)
- Applicant: Guangzhou Red Pine Medical Instrument Co., Ltd.
- Decided: Aug 8, 2025 after 28 days
- Product code: FAJ (Cystoscope 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: 7 generations back to K931154 (1993). 20 ancestors in all.
No later device cites it as a predicate yet.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241500: Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS), Guangzhou Red Pine Medical Instrument Co., Ltd. (2024) Summary page 5.

## Indications for use
This product shall be used in conjunction with the Endoscopic Video Image Processor and other peripheral equipment for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product shall not be used for other purposes.

Source page: https://510kreport.com/device/K252176
Methodology: https://510kreport.com/methodology