510(k) K253525

Device

Urocross Expander System (Model Numbers ES2018 and ES3025)

Applicant

Prodeon Medical, Inc.

510(k) number

K253525

Product code

QKA

Decision

Substantially Equivalent (SESE)

Decision date

2026-03-12

Date received

2025-11-13

Regulation

876.5510

Classification name

Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

Medical specialty

Gastroenterology, Urology

Review panel

Gastroenterology, Urology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N