# K251469: Endura™ Ureteral Stent and Stent Set

- Pathway: 510(k) (Traditional)
- Applicant: Cathegenix (Xiamen) Co., Ltd.
- Decided: Dec 19, 2025 after 220 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903345 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022447: Bard ER Ureteral Stent with Suture, C.R. Bard, Inc. (2003) Summary page 5.

## Indications for use
The device is indicated to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions in the ureter. The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic techniques. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device.

Source page: https://510kreport.com/device/K251469
Methodology: https://510kreport.com/methodology