FDA Registration
Active
🇺🇸 United States
ArcTV Transvaginal Sling System
Reg #: 3013859837
·
FEI: 3013859837
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- UROCURE, LLC
- Registration Number
- 3013859837
- FEI Number
- 3013859837
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 701 North 3rd Street, Suite 110
- City
- Minneapolis
- State
- MN
- ZIP
- 55401
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183134
Owner / Operator
- Firm Name
- UroCure, LLC
- Operator Number
- 10061024
- Address
- 701 North 3rd Street, Suite 110
- City
- Minneapolis
- State
- MN
- Postal Code
- 55401
- Country
- US
- Correspondent
- Denise Lenz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | Class 2 | General, Plastic Surgery | No | 2019-07-31 |
Proprietary Names
ArcTV Transvaginal Sling System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility