# K043021: Stryker Ureteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Mar 16, 2005 after 133 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Olympus OES 4000 Ureteroscopes: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K043021
Methodology: https://510kreport.com/methodology