# K031278: Stryker Flexible Ureteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Oct 16, 2003 after 177 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 K970427 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970427: Ksea Uretero-Reno-Fiberscope and Nephro-Fiberscope, Karl Storz Endoscopy (1997) Summary page 1.

## Indications for use
The Stryker Flexible Ureteroscope is indicated for use during minimally invasive urological procedures accessed through natural body orifices and is intended for, but not limited to transurethral examination of the upper urinary tract including the ureter, and kidney and, utilizing additional accessories for various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K031278
Methodology: https://510kreport.com/methodology