# K243550: KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Jun 6, 2025 after 203 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)
- K141250: Flexible Video-Uretero-Renoscope System, KARL STORZ Endoscopy-America, Inc. (2014) Summary page 5.

## Indications for use
The KARL STORZ Flexible Video-Uretero-Renoscope is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories,

Source page: https://510kreport.com/device/K243550
Methodology: https://510kreport.com/methodology