W. L. Gore and Associates, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “W. L. Gore and Associates, Inc.” (first 2018, latest 2022), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 159 days. Since 2017 the median was 159 days, against 104 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 |
|---|---|---|
| 2018 | 2 | 169 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 84 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name W. L. Gore and Associates, Inc. took a median 159 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 1 | 1 |
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | 1 | 0 |
| MJN | Catheter, Intravascular Occluding, Temporary | 1 | 1 |
| OXF | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | 1 | 1 |
Review panels
Most recent W. L. Gore and Associates, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222919 | GORE® ENFORM Biomaterial | OXF | 2022-12-19 | 84 |
| K180919 | GORE Tri-Lumen Catheter | DQY | 2018-10-05 | 179 |
| K172567 | GORE Molding and Occlusion Balloon Catheter | MJN | 2018-01-31 | 159 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200030 | PMA | Gore Excluder Conformable AAA Endoprosthesis (CEXC) | 2020-12-22 |
Recalls
openFDA lists no recalls under a recalling firm named W. L. Gore and Associates, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under W. L. Gore and Associates, Inc.?
FDA lists 3 510(k) clearances under the applicant name “W. L. Gore and Associates, Inc.” (first 2018, latest 2022), plus 1 PMA decision, across 4 product codes in 2 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 and Associates, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name W. L. Gore and Associates, Inc. is 159 days. Since 2017: 159 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under W. L. Gore and Associates, Inc.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 1); MIH (System, Endovascular Graft, Aortic Aneurysm Treatment, 1); MJN (Catheter, Intravascular Occluding, Temporary, 1).
Next steps
- See all 3 W. L. Gore and Associates, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, W. L. Gore and 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.