Data / Medical devices / United States / W. L. Gore & Associates, Inc
W. L. Gore & Associates, Inc: FDA-registered device maker in Flagstaff, AZ, United States, 14 510(k) clearances and 8 PMA approvals
W. L. Gore & Associates, Inc is registered with the FDA (registration 2017233) in Flagstaff, AZ, United States. It lists 10 device types. The FDA files 14 510(k) clearances and 8 PMA approvals under its listings, the newest dated March 1, 2024. 15 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2017233
- Address
- 1505 North Fourth ST., Flagstaff, AZ, United States, 86004
- Owner or operator
- W. L. GORE & ASSOCIATES, INC. (9925013)
- Roles
- Manufacturer
- First device listed
- August 16, 2005
- Registered through
- 2027
- Brand names listed
- Axillobifemoral GORE-TEX® Vascular Graft, Bifurcated GORE-TEX® Stretch Vascular Graft, Bifurcated Gore-Tex Stretch VG, Custom Device GO, FEP Ringed GORE-TEX® Stretch Vascular Graft, FEP Ringed GORE-TEX® Stretch Vascular Graft with Removable Rings, GORE TAG Conformable Endoprosthesis/GORE TAG Conformable Endoprosthesis with Active Control, GORE-TEX® STRETCH Vascular Graft and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions | SDZ | 3 | Manufacturer | accessdata.fda.gov |
| Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions | QZK | 3 | Manufacturer | accessdata.fda.gov |
| Iliac Covered Stent, Arterial | PRL | 3 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | DSY | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | DYF | 2 | Manufacturer | accessdata.fda.gov |
| Stent, Superficial Femoral Artery | NIP | 3 | Manufacturer | accessdata.fda.gov |
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | 3 | Manufacturer | accessdata.fda.gov |
| System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment | PFV | 3 | Manufacturer | accessdata.fda.gov |
| Transcatheter Septal Occluder | MLV | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 1, 2024 | K240083 | GORE® PROPATEN® Vascular Graft | DSY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| December 19, 2023 | K233551 | GORE® ACUSEAL Vascular Graft | DSY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| October 5, 2018 | K180919 | GORE Tri-Lumen Catheter | DQY | Substantially Equivalent | W. L. Gore and Associates, Inc. | accessdata.fda.gov |
| October 3, 2008 | K081799 | GORE TRI-LOBE BALLOON CATHETER | DQY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| October 26, 2001 | K013250 | GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT | DSY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| July 9, 1999 | K991602 | EPTFE RINGED GORE-TEX VASCULAR GRAFT | DSY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| December 8, 1993 | K933943 | FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS | DSY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| November 24, 1992 | K922905 | FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT | DSY | Unknown | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| November 5, 1991 | K914447 | GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE | DSY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| January 16, 1991 | K904282 | BIFURCATED GORE TEX STRETCH VASCULAR GRAFT | DSY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| December 6, 1990 | K903931 | GORE-TEX(R) STRETCH VASCULAR GRAFT | DSY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| September 5, 1990 | K901641 | AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT | DSY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| May 18, 1988 | K880167 | GORE-TEX VASCULAR GRAFT | DSY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| August 20, 1981 | K811510 | GORE-TEX VASULAR GRAFT | DSY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 12, 2024 | P230023 | GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis | QZK | 12 | July 1, 2026 | accessdata.fda.gov |
| May 13, 2022 | P210032 | GORE TAG Thoracic Branch Endoprosthesis (TBE Device) | MIH | 26 | July 13, 2026 | accessdata.fda.gov |
| January 27, 2017 | P160021 | GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS | PRL | 49 | October 8, 2026 | accessdata.fda.gov |
| December 5, 2013 | P130006 | GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE | PFV | 107 | May 26, 2026 | accessdata.fda.gov |
| August 11, 2006 | P050006 | GORE HELEX SEPTAL OCCLUDER | MLV | 114 | August 3, 2026 | accessdata.fda.gov |
| June 14, 2005 | P040037 | VIABAHN ENDOPROSTHESIS | NIP | 165 | May 26, 2026 | accessdata.fda.gov |
| March 23, 2005 | P040043 | GORE TAG THORACIC ENDOPROSTHESIS | MIH | 141 | March 9, 2026 | accessdata.fda.gov |
| November 6, 2002 | P020004 | EXCLUDER BIFURCATED ENDOPROSTHESIS | MIH | 199 | July 8, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 3, 2026 | 99873 | Class II | Ongoing | Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthes | The potential for the devices to be mislabeled with the incorrect length. | accessdata.fda.gov |
| May 22, 2026 | 99143 | Class II | Ongoing | GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). | accessdata.fda.gov |
| May 19, 2026 | 99140 | Class II | Ongoing | GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706 | Due to catheter separation | accessdata.fda.gov |
| August 26, 2025 | 97474 | Class II | Ongoing | GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH4700 | Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to devic | accessdata.fda.gov |
| July 1, 2024 | 94971 | Class II | Ongoing | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB0559 | Due to packaging defects, sterility assurance and heparin activity may be compromised. | accessdata.fda.gov |
| December 14, 2022 | 91380 | Class II | Ongoing | GORE CARDIOFORM Septal Occluder, REF: GSX0030A | Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture. | accessdata.fda.gov |
| September 21, 2022 | 90912 | Class II | Ongoing | GORE CARDIOFORM ASD Occluder. cardiovascular implant. | Due to manufacturing records (Release Test Results) indicating "Failed". | accessdata.fda.gov |
| September 7, 2021 | 88721 | Class II | Ongoing | Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI: | Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device. | accessdata.fda.gov |
| September 2, 2021 | 88683 | Class II | Ongoing | REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032 | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. | accessdata.fda.gov |
| May 12, 2021 | 88245 | Class II | Ongoing | Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337 | Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm. | accessdata.fda.gov |
| September 9, 2020 | 86421 | Class II | Ongoing | GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System | When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn. | accessdata.fda.gov |
| September 9, 2020 | 86420 | Class II | Ongoing | GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System | Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible | accessdata.fda.gov |
| December 17, 2019 | 85434 | Class II | Terminated | Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta. | The incorrect label was placed on both the primary and secondary package. | accessdata.fda.gov |
| September 25, 2017 | 78132 | Class II | Terminated | GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta. | Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure. | accessdata.fda.gov |
| April 28, 2006 | 35507 | Not yet classified | Terminated | GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm | Two lots of uniquely different product were switched and mislabeled with the wrong length. 34mm x 10cm devices were mislabeled as 34mm x 15cm and vice versa. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- All makers of Stent, Superficial Femoral Artery
- All makers of System, Endovascular Graft, Aortic Aneurysm Treatment
- All makers of Transcatheter Septal Occluder
- All makers of Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Updated October 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.