W. L. Gore & Associates, Inc.: FDA filings under this applicant name
FDA lists 169 510(k) clearances under 3 spellings of the applicant name “W. L. Gore & Associates, Inc.” (first 1980, latest 2025), plus 13 PMA decisions, across 56 product codes in 12 review panels. Median 510(k) review time under this name: 84 days. Since 2017 the median was 85 days, against 115 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 66 |
| 2013 | 2 | 81 |
| 2014 | 1 | 279 |
| 2015 | 2 | 57 |
| 2016 | 1 | 101 |
| 2017 | 3 | 86 |
| 2018 | 4 | 162 |
| 2019 | 1 | 29 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 84 |
| 2023 | 2 | 38 |
| 2024 | 2 | 105 |
| 2025 | 1 | 109 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name W. L. Gore & Associates, Inc. took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 37 | 37 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 24 | 24 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 13 | 13 |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 8 | 8 |
| DYB | Introducer, Catheter | 7 | 7 |
| LYC | Bone Grafting Material, Synthetic | 5 | 5 |
| NPK | Barrier, Synthetic, Intraoral | 5 | 5 |
| DQY | Catheter, Percutaneous | 4 | 4 |
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | 4 | 0 |
| MOS | Coil, Magnetic Resonance, Specialty | 4 | 4 |
Plus 46 more product codes.
Review panels
- Cardiovascular (78)
- General and Plastic Surgery (59)
- Dental (11)
- Orthopedic (7)
- Gastroenterology and Urology (5)
- General Hospital (5)
- Neurology (5)
- Radiology (4)
- Anesthesiology (3)
- Ear, Nose and Throat (1)
- Immunology (1)
- Ophthalmic (1)
Most recent W. L. Gore & Associates, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250410 | GORE® Tri-Lobe Balloon Catheter | DQY | 2025-06-02 | 109 |
| K240083 | GORE® PROPATEN® Vascular Graft | DSY | 2024-03-01 | 50 |
| K232312 | GORE® PROPATEN® Vascular Graft | DSY | 2024-01-09 | 160 |
| K233551 | GORE® ACUSEAL Vascular Graft | DSY | 2023-12-19 | 46 |
| K231505 | GORE® ACUSEAL Vascular Graft | DSY | 2023-06-23 | 30 |
| K222919 | GORE® ENFORM Biomaterial | OXF | 2022-12-19 | 84 |
| K191773 | GORE BIO-A Tissue Reinforcement | OWT | 2019-07-31 | 29 |
| K180919 | GORE Tri-Lumen Catheter | DQY | 2018-10-05 | 179 |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | OXC | 2018-08-17 | 29 |
| K173333 | GORE ENFORM Biomaterial | OXF | 2018-04-05 | 164 |
159 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250017 | PMA | GORE® VIABAHN® FORTEGRA Venous Stent | 2025-12-19 |
| P230023 | PMA | GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis | 2024-01-12 |
| P210032 | PMA | GORE TAG Thoracic Branch Endoprosthesis (TBE Device) | 2022-05-13 |
| P200030 | PMA | Gore Excluder Conformable AAA Endoprosthesis (CEXC) | 2020-12-22 |
| P180010 | PMA | Gore Carotid Stent | 2018-11-01 |
Recalls
31 product recalls in 19 recall events; 10 initiated in the last five years. Most recent: 2026-05-22.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named W. L. Gore & Associates, Inc. is the lead sponsor of 78 device studies on ClinicalTrials.gov (32 active or recruiting). Most recent:
- NCT07147569: TAMBE Japan Post-Marketing Surveillance (Recruiting, started 2026-03-27)
- NCT07166133: GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study (Recruiting, started 2026-03-02)
- NCT07049913: TBE Zone 2 PMS in Japan (Recruiting, started 2025-12-15)
- NCT06827990: GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections (Recruiting, started 2025-09-22)
- NCT06658730: Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance (Recruiting, started 2025-06-19)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under W. L. Gore & Associates, Inc. (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- W. L. Gore & Associates, Inc. (175)
- W. L. Gore and Associates, Inc. (4)
- W.L. Gore & Associates (3)
Frequently asked questions
How many FDA 510(k) clearances are listed under W. L. Gore & Associates, Inc.?
FDA lists 169 510(k) clearances under 3 spellings of the applicant name “W. L. Gore & Associates, Inc.” (first 1980, latest 2025), plus 13 PMA decisions, across 56 product codes in 12 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by W. L. Gore & Associates, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name W. L. Gore & Associates, Inc. is 84 days. Since 2017: 85 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under W. L. Gore & Associates, Inc.?
The most frequent FDA product codes under this applicant name are FTL (Mesh, Surgical, Polymeric, 37); DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 24); DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 13).
Next steps
- See all 169 W. L. Gore & Associates, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTL, W. L. Gore & Associates, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.