FDA Registration
Active
🇺🇸 United States
UROVIU CORPORATION
Reg #: 3015042209
·
FEI: 3015042209
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- UROVIU CORPORATION
- Registration Number
- 3015042209
- FEI Number
- 3015042209
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4546 El Camino Real, Suite 214
- City
- Los Altos
- State
- CA
- ZIP
- 94022
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171500
Owner / Operator
- Firm Name
- UroViu Corporation
- Operator Number
- 10058555
- Address
- 4546 El Camino Real, Suite 214
- City
- Los Altos
- State
- CA
- Postal Code
- 94022
- Country
- US
- Correspondent
- Thomas Lawson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2018-10-09 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2022-06-29 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2024-10-22 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2021-08-16 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2023-08-07 |
Proprietary Names
Uro-V Cystoscope
Hystero-V Hystroscope
UroViu Drape
Uro-N Cystoscope
Uro-G HD Flexible Cystoscope
UV5000W
UroViu Grasper
Uro-G Flexible Cystoscope
UV5000 Handle
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198