# K212458: Flexible Video-Uretero-Renoscope SSU System

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America
- Decided: Jan 20, 2022 after 168 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 4.

## Indications for use
The SSU Felxible 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. E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.

Source page: https://510kreport.com/device/K212458
Methodology: https://510kreport.com/methodology