# K241532: Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd.
- Decided: Oct 22, 2024 after 145 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- 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: 11 generations back to K931154 (1993). 27 ancestors in all.
No later device cites it as a predicate yet.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211686: Flexible Video-Choledo-Cysto-Ureteroscope System, Shanghai SeeGen Photoelectric Technology Co., Ltd. (2022) Summary page 5.

## 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/K241532
Methodology: https://510kreport.com/methodology