FDA Registration
Active
🇺🇸 United States
UROCURE, LLC
Reg #: 3013859837
·
FEI: 3013859837
·
Expires 2026
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- UROCURE, LLC
- Registration Number
- 3013859837
- FEI Number
- 3013859837
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1856 Corporate Dr Ste 135
- City
- Norcross
- State
- GA
- ZIP
- 30093
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222293
Owner / Operator
- Firm Name
- UroCure, LLC
- Operator Number
- 10061024
- Address
- 1856 Corporate Drive, Suite 135
- City
- Norcross
- State
- GA
- Postal Code
- 30093
- Country
- US
- Correspondent
- Pawel Lukaszewicz
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 | 2022-12-09 |
Proprietary Names
ArcSP
ArcTO
ArcTV Transvaginal Sling System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility