# K261342: Urocross Expander System (UES-2018-C1)

- Pathway: 510(k) (Traditional)
- Applicant: Prodeon Medical, Inc.
- Decided: Jun 22, 2026 after 60 days
- Product code: QKA (Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia)
- Device class: 2
- Regulation: 21 CFR 876.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN190020 (2020). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253525: Urocross Expander System (Model Numbers ES2018 and ES3025), Prodeon Medical, Inc. (2026) Summary page 5.

## Indications for use
The Urocross Expander System is intended to relieve urinary outflow obstruction. The Urocross Expander System is indicated for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) in men ≥ 45 years old. The Urocross Expander Implant is indicated for an indwell duration of up to 6 months.

Source page: https://510kreport.com/device/K261342
Methodology: https://510kreport.com/methodology