Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list W. L. Gore & Associates and its 2 subsidiaries with 171 510(k) clearances and 32 device recalls. The most recent is a 510(k) clearance dated Jun 2, 2025: GORE® Tri-Lobe Balloon Catheter.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, W. L. Gore & Associates and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 2, 2025 | GORE® Tri-Lobe Balloon CatheterK250410 · DQY | 510(k) clearances |
| Jul 3, 2024 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;Class II · Devices were labeled with an expiration date of four years and ten days rather than the validated two years. | Device recalls |
| Mar 1, 2024 | GORE® PROPATEN® Vascular GraftK240083 · DSY | 510(k) clearances |
| Jan 19, 2024 | GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) CataloClass II · Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Po | Device recalls |
| Jan 9, 2024 | GORE® PROPATEN® Vascular GraftK232312 · DSY | 510(k) clearances |
| Dec 19, 2023 | GORE® ACUSEAL Vascular GraftK233551 · DSY | 510(k) clearances |
| Jun 23, 2023 | GORE® ACUSEAL Vascular GraftK231505 · DSY | 510(k) clearances |
| Dec 19, 2022 | GORE® ENFORM BiomaterialK222919 · OXF | 510(k) clearances |
| Apr 5, 2021 | GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VNClass II · The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter | Device recalls |
| Jul 31, 2019 | GORE BIO-A Tissue ReinforcementK191773 · OWT | 510(k) clearances |
| Oct 5, 2018 | GORE Tri-Lumen CatheterK180919 · DQY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
