GORE-TEX(TM) SUTURE
FDA premarket approval P820083/S025 · decided 1998-08-27
Approval details
- PMA number
- P820083
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GORE-TEX(TM) SUTURE
- Generic name
- Suture, nonabsorbable, synthetic, polypropylene
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 1998-07-23
- Decision date
- 1998-08-27
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- GAW
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- Approval for 1) a change in suture needle material 2) a change in suture needle geometry, and 3) addition of a silicone coating to the suture needle.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® Tri-Lobe Balloon Catheter (K250410) | W. L. Gore & Associates, Inc. | 2025-06-02 |
| GORE® PROPATEN® Vascular Graft (K240083) | W. L. Gore & Associates, Inc. | 2024-03-01 |
| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
| GORE® ACUSEAL Vascular Graft (K231505) | W. L. Gore & Associates, Inc. | 2023-06-23 |
| GORE BIO-A Tissue Reinforcement (K191773) | W. L. Gore & Associates, Inc. | 2019-07-31 |
| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) | W. L. Gore & Associates, Inc. | 2018-08-17 |
| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |