# K180354: UroGen Ureteral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Urogen Pharma, Ltd.
- Decided: Oct 30, 2018 after 264 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K965229 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110491: Backstop Catheter, Pluromed, Inc. (2011) Summary page 4.

## Most influential descendants
- K211032: Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (2021), 0 descendants of its own

## Indications for use
The UroGen Ureteral Catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract.

Source page: https://510kreport.com/device/K180354
Methodology: https://510kreport.com/methodology