Urotronic, Inc.
FDA 510(k) & PMA Approved Devices — 4 products
Total Devices4
Categories4
Latest FDA decision2025-12-15
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P220029 | Drug coated prostatic dilation catheter for benign prostatic hyperplasia | QXB | 2025-12-15 | View |
| PMA | P210020 | Catheter, Balloon, Urethral, Drug-Coated | QRH | 2025-06-23 | View |
| 510(k) | K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | EZN | 2025-05-22 | View |
| 510(k) | K191061 | Optilume Basic Urological Balloon Dilation Catheter | KOE | 2020-01-02 | View |
No matching devices.
Related Clinical Trials
NCT03499964ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture DiseaseACTIVE_NOT_RECRUITINGNCT04131907Optilume™ BPH Catheter System in Men With Symptomatic BPHACTIVE_NOT_RECRUITINGNCT06312722Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market StudyRECRUITING