FDA Registration
Active
🇺🇸 United States
UROTRONIC INC
Reg #: 3015228875
·
FEI: 3015228875
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- UROTRONIC INC
- Registration Number
- 3015228875
- FEI Number
- 3015228875
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2495 Xenium Lane North
- City
- Plymouth
- State
- MN
- ZIP
- 55441
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191061
- PMA Number
- P210020
Owner / Operator
- Firm Name
- Urotronic Inc
- Operator Number
- 10063084
- Address
- 2495 Xenium Lane North
- City
- Plymouth
- State
- MN
- Postal Code
- 55441
- Country
- US
- Correspondent
- Nicole Boser
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2020-03-16 |
| Catheter, Balloon, Urethral, Drug-Coated | QRH | Class 3 | Unknown | No | 2021-12-06 |
| Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia | QXB | Class 3 | Unknown | No | 2023-07-06 |
Proprietary Names
Optilume Basic Urological Balloon Dilation Catheter
Optilume® Urethral Drug Coated Balloon
Optilume BPH Catheter System
Establishment Types
Manufacture Medical Device