FDA Registration
Active
🇺🇸 United States
W. L. GORE & ASSOCIATES, INC.
Reg #: 3003910212
·
FEI: 3003910212
·
Expires 2026
Products
8
Proprietary Names
16
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- W. L. GORE & ASSOCIATES, INC.
- Registration Number
- 3003910212
- FEI Number
- 3003910212
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 301 AIRPORT RD.
- City
- ELKTON
- State
- MD
- ZIP
- 21921
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152609
- PMA Number
- P820083
Owner / Operator
- Firm Name
- W. L. GORE & ASSOCIATES, INC.
- Operator Number
- 9925013
- Address
- 1505 North Fourth Street
- City
- Flagstaff
- State
- AZ
- Postal Code
- 86004
- Country
- US
- Correspondent
- Lisa Wells
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2006-09-15 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2016-02-19 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2017-05-08 |
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | Class 2 | General, Plastic Surgery | No | 2023-02-10 |
| Mesh, Surgical, Absorbable, Staple Line Reinforcement | OXC | Class 2 | General, Plastic Surgery | No | 2023-02-10 |
| Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | OXF | Class 2 | General, Plastic Surgery | No | 2023-02-10 |
| Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction | OWZ | Class 2 | General, Plastic Surgery | No | 2023-02-10 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2018-10-23 |
Proprietary Names
GORE-TEX® SUTURE
GORE ® SYNECOR Intraperitoneal Biomaterial
GORE-TEX Soft Tissue Patch
GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement (Configured for Endoscopic Staplers)
GORE ® VIABIL ® Short Wire Biliary Endoprosthesis
GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement (Configured for Circular Staplers)
GORE® BIO-A® Flex Intraperitoneal Tissue Reinforcement
GORE® ENFORM INTRAPERITONEAL Biomaterial
GORE® ENFORM PREPERITONEAL Biomaterial
GORE® BIO-A® Flex Preperitoneal Tissue Reinforcement
GORE® Tri-Lumen Catheter
GORE® DUALMESH® Biomaterial
GORE ® VIABIL ® Biliary Endoprosthesis
GORE® BIO-A® Tissue Reinforcement
GORE® SYNECOR Preperitoneal Biomaterial
GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement (Configured for Robotic Endoscopic Staplers)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198