FDA Registration
Active
🇺🇸 United States
GYNECARE TVT System, Abdominal Guides System, Introducer and Catheter Guide, EXACT, Obturator, ABBREVO
Reg #: 3003990090
·
FEI: 3003990090
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- CALDERA MEDICAL, INC.
- Registration Number
- 3003990090
- FEI Number
- 3003990090
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4360 Park Terrace Drive
- City
- Westlake Village
- State
- CA
- ZIP
- 91361
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201686
Owner / Operator
- Firm Name
- Caldera Medical
- Operator Number
- 10028052
- Address
- 4360 Park Terrace Drive
- City
- Westlake Village
- State
- CA
- Postal Code
- 91361
- Country
- US
- Correspondent
- Vicki Gail
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence | PWJ | Class 2 | Obstetrics/Gynecology | No | 2025-06-30 |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | Class 2 | General, Plastic Surgery | No | 2025-06-30 |
Proprietary Names
GYNECARE TVT System, Abdominal Guides System, Introducer and Catheter Guide, EXACT, Obturator, ABBREVO
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility