Chrysalis Intelligence · Sponsors · W. L. Gore and Associates, Inc.

W. L. Gore and Associates, Inc.

Elkton, MD, US · 1 510(k) clearances · 27 PMAs

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Total clearances
1
2022-12-19 → 2022-12-19
Last 12 months
0
Product codes
1
Most recent
2022-12-19
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery Class II General, Plastic Surgery 1 2022-12-19
Class III

PMA approvals (27)

Total PMA records
27
Originals + supplements
Distinct product codes
1
First decision
2020-12-22
Most recent
2026-07-29
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-29 P200030-S026 GORE® EXCLUDER® Conformable AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-07-08 P200030-S025 GORE® EXCLUDER® Conformable AAA Endoprosthesis Real-Time Process MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-05-14 P200030-S024 GORE® EXCLUDER® Conformable AAA Endoprosthesis Real-Time Process MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-12-05 P200030-S023 GORE® EXCLUDER® Conformable AAA Endoprosthesis Real-Time Process MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-08-29 P200030-S022 GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 00733132650927; 00733132650934; 00733132650941; 00733132650958; 00 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-06-05 P200030-S021 GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-06-05 P200030-S020 GORE EXCLUDER Conformable AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-03-11 P200030-S019 GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-12-04 P200030-S016 GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-09-06 P200030-S018 GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-06-21 P200030-S017 Gore Excluder Conformable AAA Endoprosthesis (CEXC) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-04-05 P200030-S014 GORE®1 EXCLUDER® Conformable AAA Endoprosthesis (CEXC), GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) Panel Track MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-11-02 P200030-S015 Gore Excluder Conformable AAA Endoprosthesis(EXCC) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-10-10 P200030-S013 GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-06-20 P200030-S012 GORE® EXCLUDER® Conformable AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-03-14 P200030-S011 GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-10-05 P200030-S010 GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-08-16 P200030-S009 GORE® EXCLUDER® Conformable AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-07-27 P200030-S008 GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-02-22 P200030-S007 GORE® Excluder® Conformable AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-12-16 P200030-S006 Gore Excluder Conformable AAA Endoprosthesis (EXCC) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-11-22 P200030-S005 GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-10-06 P200030-S004 GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-06-09 P200030-S003 GORE® EXCLUDER® Conformable AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-04-15 P200030-S002 GORE EXCLUDER Conformable AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-02-01 P200030-S001 Gore Excluder Conformable AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-12-22 P200030 Gore Excluder Conformable AAA Endoprosthesis (CEXC) Original MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2022-12-19 K222919 GORE® ENFORM Biomaterial OXF Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-08-11 12:14 · Last ingest 2026-08-11T16:13:49.849860 · Pipeline: Chrysalis Intelligence