# K250049: Medical Video Endoscope [Standard Deflection]  (URS3005); Medical Video Endoscope [Reverse Deflection]  (URS3005E); Medical Video Endoscope [Standard Deflection]  (URS3006); Medical Video Endoscope [Reverse Deflection]  (URS3006E); Medical Video Endoscope [Standard Deflection]  (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)

- Pathway: 510(k) (Traditional)
- Applicant: Seplou (Zhuhai) Co., Ltd.
- Decided: Aug 26, 2025 after 228 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 Medical Video Endoscope is designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. The image processor is used with the specified endoscope designed by SEPLOU during minimally invasive surgery. The image processor provides power and processes the images for medical electronic endoscope.

Source page: https://510kreport.com/device/K250049
Methodology: https://510kreport.com/methodology