Urotronic, Inc.
Medical device manufacturer in Minneapolis, MN.
2510(k) clearances
2PMA approvals
0recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|
| K250910 | Optilume® High Pressure Urological Balloon Dilation CatheterEZN · Traditional |
05/22/2025SE |
| K191061 | Optilume Basic Urological Balloon Dilation CatheterKOE · Traditional |
01/02/2020SE |
PMA approvals
- P220029 Optilume BPH Catheter System · 06/30/2023 · 4 supplements
- P210020 Optilume Urethral Drug Coated Balloon · 12/03/2021 · 9 supplements