Optilume® High Pressure Urological Balloon Dilation Catheter
FDA 510(k) clearance K250910 · decided 2025-05-22
Clearance details
- K-number
- K250910
- Device name
- Optilume® High Pressure Urological Balloon Dilation Catheter
- Applicant
- Urotronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-26
- Decision date
- 2025-05-22
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- EZN
- Device class
- 2
- Regulation number
- 876.5470
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Optilume BPH Catheter System (P220029/S003) | Urotronic, Inc. | 2025-12-15 |
| Optilume BPH Catheter System (P220029/S004) | Urotronic, Inc. | 2025-12-12 |
| Optilume Urethral Drug Coated Balloon Catheter (P210020/S010) | Urotronic, Inc. | 2025-06-23 |
| Optilume BPH Catheter System (P220029/S002) | Urotronic, Inc. | 2024-08-15 |
| Optilume Urethral Drug Coated Balloon catheter (P210020/S009) | Urotronic, Inc. | 2024-01-13 |
| Optilume BPH Catheter System (P220029/S001) | Urotronic, Inc. | 2023-08-25 |
| Optilume BPH Catheter System (P220029) | Urotronic, Inc. | 2023-06-30 |
| Optilume Urethral Drug Coated Balloon (P210020/S008) | Urotronic, Inc. | 2023-04-25 |