# W. L. Gore & Associates, Inc.

- Location (FDA's records): Flagstaff, AZ
- FDA decisions: 175 (1980–2025): 163 510(k) clearances and 12 original PMA approvals
- Product codes: FTL (36), DSY (23), DXZ (13), DYF (8), DYB (7), NPK (5), LYC (5), MOS (4), JCT (3), MIH (3), FWP (3), HRX (3)
- 510(k) review time since 2016: median 105 days, against 124 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 106 (59 its own); citations of its devices by later devices: 158 (59 its own)
- Recalls linked to its devices: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ETHICON, Inc.: 5 (https://510kreport.com/company/ethicon)
- Integra LifeSciences Corporation: 3 (https://510kreport.com/company/integra-lifesciences)
- Arteria Medical Science, Inc.: 3 (https://510kreport.com/company/arteria-medical-science)
- Cook, Inc.: 3 (https://510kreport.com/company/cook)
- General Electric Co.: 3 (https://510kreport.com/company/general-electric)
- Cook Biotech, Inc.: 2 (https://510kreport.com/company/cook-biotech)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Holter-Hausner Intl.: 1 (https://510kreport.com/company/holter-hausner-intl)

## Firms that cite its devices most
- Meadox Medicals, Div. Boston Scientific Corp.: 9 (https://510kreport.com/company/meadox-medicals-div-boston-scientific)
- C.R. Bard, Inc.: 5 (https://510kreport.com/company/cr-bard)
- W.L. Gore & Associates: 4 (https://510kreport.com/company/wl-gore-associates)
- Samyang Corp.: 3 (https://510kreport.com/company/samyang)
- Synovis Surgical Innovations: 2 (https://510kreport.com/company/synovis-surgical-innovations)
- Unicare Biomedical, Inc.: 2 (https://510kreport.com/company/unicare-biomedical)
- Cook Biotech, Inc.: 2 (https://510kreport.com/company/cook-biotech)
- Replication Medical, Inc.: 2 (https://510kreport.com/company/replication-medical)

## Its most-cited devices
- K033671: Gore Bioabsorbable Mesh (2003), cited by 7
- K043056: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2004), cited by 7
- K093791: Gore Dryseal Sheath (2010), cited by 6
- K160254: GORE DrySeal Flex Introducer Sheath (2016), cited by 6
- K992189: Gore-Tex Dualmesh Biomaterial (1999), cited by 5
- K032865: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), cited by 4

## Recent decisions
- P250017: GORE® VIABAHN® FORTEGRA Venous Stent (Dec 19, 2025)
- K250410: GORE® Tri-Lobe Balloon Catheter (Jun 2, 2025)
- K240083: GORE® PROPATEN® Vascular Graft (Mar 1, 2024)
- P230023: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (Jan 12, 2024)
- K232312: GORE® PROPATEN® Vascular Graft (Jan 9, 2024)
- K233551: GORE® ACUSEAL Vascular Graft (Dec 19, 2023)
- K231505: GORE® ACUSEAL Vascular Graft (Jun 23, 2023)
- P210032: GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (May 13, 2022)

Source page: https://510kreport.com/company/w-l-gore-associates