# K970427: Ksea Uretero-Reno-Fiberscope and Nephro-Fiberscope

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: Mar 11, 1997 after 35 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
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K043022: Stryker Flexible Cystonephroscope (2005), 11 descendants of its own
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K141358: Cellvizio 100 Series with System Confocal Miniprobes (2014), 9 descendants of its own
- K160416: CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes (2016), 7 descendants of its own
- K150831: Cellvizio 100 Series System with Confocal Miniprobes (2015), 7 descendants of its own

## Indications for use
The KSEA Uretero-Reno-Fiberscope and Nephro-Fiberscope is designed to be used by qualified surgeons and physicians for examination of the upper urinary tract including the ureter and kidney and, using additional accessories, io perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K970427
Methodology: https://510kreport.com/methodology