# K131369: Flexible Video-Uretero-Renoscope System

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Nov 26, 2013 after 197 days
- Product code: FGB (Ureteroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931154 (1993). 23 ancestors in all.
53 later devices descend from it; 5 cite it directly.
2 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System, Acmi Corporation (2006) Summary page 1.
- K003325: Ksi's New Camera Architecture (Nca) Video Imaging System, Karl Storz Imaging, Inc. (2001) Summary page 1.

## Most influential descendants
- K172098: Medical Video Endoscope System (2017), 23 descendants of its own
- K141250: Flexible Video-Uretero-Renoscope System (2014), 11 descendants of its own
- K180367: Ureterorenoscope System (2018), 9 descendants of its own
- K142556: Flexible Video-Uretero-Choledochoscope System (2014), 7 descendants of its own
- K201293: Ureterorenoscope System (2020), 4 descendants of its own

## Recalls of this device
- Apr 1, 2022 · Class II · Z-1068-2022: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

## Indications for use
The Karl Storz Flexible Video-Uretero-Renoscope System is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K131369
Methodology: https://510kreport.com/methodology