# K232911: KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endovision, Inc.
- Decided: Jun 10, 2024 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: 1 generation back to K925128 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982905: MVM 7.5 French Flexible Ureteroscope, Karl Storz Endoscopy (1998) Summary page 5.
- K925128: The Karl Storz 11274 Series Flexible Fiberscope, KARL STORZ Endoscopy-America, Inc. (1993) Summary page 5.

## Indications for use
The KARL STORZ Flexible Uretero-Reno-Fiberscope is indicated for examination of the upper urinary tract including the ureter and kidneys and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K232911
Methodology: https://510kreport.com/methodology