# K043022: Stryker Flexible Cystonephroscope

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Mar 15, 2005 after 132 days
- Product code: FAJ (Cystoscope 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 K904797 (1991). 2 ancestors in all.
11 later devices descend from it; 1 cites 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)
- K904797: Surgitek Graduated Cystoscope (Model GC-16), Surgitek (1991) Summary page 1.
- K970427: Ksea Uretero-Reno-Fiberscope and Nephro-Fiberscope, Karl Storz Endoscopy (1997) Summary page 1.

## Most influential descendants
- 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
- K172844: Cellvizio 100 Series System with Confocal Miniprobes (2017), 6 descendants of its own

## Indications for use
The Stryker Flexible CystoNephroscope is indicated for use during minimally invasive urological procedures accessed through natural body orifices or through percutaneous access, and is intended for but not limited to, examining the urinary tract and the interior of the kidney, and, using additional accessories, performing various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K043022
Methodology: https://510kreport.com/methodology