# K211686: Flexible Video-Choledo-Cysto-Ureteroscope System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd.
- Decided: Feb 22, 2022 after 265 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.
2 later devices descend from it; 2 cite it directly.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142556: Flexible Video-Uretero-Choledochoscope System, KARL STORZ Endoscopy-America, Inc. (2014) Summary page 5.

## Most influential descendants
- K241532: Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (2024), 0 descendants of its own
- K223741: Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) (2023), 0 descendants of its own

## Indications for use
The Flexible Video-Choledo-Cysto-Ureteroscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Choledo-Cysto-Ureteroscope System is also indicated for the examination of bile ducts surgically, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Source page: https://510kreport.com/device/K211686
Methodology: https://510kreport.com/methodology