K253525 is an FDA 510(k) clearance for the Urocross Expander System (Model Numbers ES2018 and ES3025). This device is classified as a Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia (Class II - Special Controls, product code QKA).
Submitted by Prodeon Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 12, 2026, 119 days after receiving the submission on November 13, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5510. A System Intended For The Treatment Of Symptoms Due To Urinary Outflow Obstruction Secondary To Benign Prostatic Hyperplasia (bph) In Men Age 50 And Above..
| 510(k) Number | K253525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2025 |
| Decision Date | March 12, 2026 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QKA — Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5510 |
| Definition | A System Intended For The Treatment Of Symptoms Due To Urinary Outflow Obstruction Secondary To Benign Prostatic Hyperplasia (bph) In Men Age 50 And Above. |