Urotronic, Inc.
FDA 510(k) & PMA Approved Devices — 4 products
Total Devices4
Categories4
Latest Approval2025-05-22
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | EZN | 2025-05-22 | View |
| PMA | P220029 | Drug coated prostatic dilation catheter for benign prostatic hyperplasia | QXB | 2023-08-25 | View |
| PMA | P210020 | Catheter, Balloon, Urethral, Drug-Coated | QRH | 2021-12-03 | View |
| 510(k) | K191061 | Optilume Basic Urological Balloon Dilation Catheter | KOE | 2020-01-02 | View |
No matching devices.