# K211032: Urinary Catheter 12 Fr, Urinary Catheter 16 Fr

- Pathway: 510(k) (Traditional)
- Applicant: Urogen Pharma, Ltd.
- Decided: Nov 19, 2021 after 226 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: 6 generations back to K965229 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180354: UroGen Ureteral Catheter, Urogen Pharma, Ltd. (2018) Summary page 5.

## Indications for use
The Urinary Catheter is indicated for use to facilitate access to the urinary tract through a retrograde route for the delivery of gels or fluids into the urinary tract.

Source page: https://510kreport.com/device/K211032
Methodology: https://510kreport.com/methodology