Data / Medical devices / United States / W. L. Gore & Associates, Inc.
W. L. Gore & Associates, Inc.: FDA-registered device maker in Elkton, MD, United States, 14 510(k) clearances and 1 PMA approval
W. L. Gore & Associates, Inc. is registered with the FDA (registration 3003910212) in Elkton, MD, United States. It lists 8 device types. The FDA files 14 510(k) clearances and 1 PMA approval under its listings, the newest dated December 19, 2022. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003910212
- Address
- 301 Airport RD., Elkton, MD, United States, 21921
- Owner or operator
- W. L. GORE & ASSOCIATES, INC. (9925013)
- Roles
- Manufacturer
- First device listed
- September 15, 2006
- Registered through
- 2027
- Brand names listed
- GORE ® SYNECOR Intraperitoneal Biomaterial, GORE ® VIABIL ® Biliary Endoprosthesis, GORE ® VIABIL ® Short Wire Biliary Endoprosthesis, GORE-TEX Soft Tissue Patch, GORE-TEX® SUTURE, GORE® BIO-A® Flex Intraperitoneal Tissue Reinforcement, GORE® BIO-A® Flex Preperitoneal Tissue Reinforcement, GORE® BIO-A® Tissue Reinforcement and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | OXF | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Staple Line Reinforcement | OXC | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction | OWZ | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Manufacturer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | 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 |
|---|---|---|---|---|---|---|
| December 19, 2022 | K222919 | GORE® ENFORM Biomaterial | OXF | Substantially Equivalent | W. L. Gore and Associates, Inc. | accessdata.fda.gov |
| July 31, 2019 | K191773 | GORE BIO-A Tissue Reinforcement | OWT | 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 |
| August 17, 2018 | K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | OXC | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| May 11, 2017 | K163576 | GORE SYNECOR Preperitoneal Biomaterial | FTL | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| May 8, 2017 | K170740 | GORE VIABIL Short Wire Biliary Endoprosthesis | FGE | Unknown | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| December 11, 2015 | K152609 | GORE SYNECOR Biomaterial | FTL | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| July 22, 2008 | K081184 | GORE VIABIL BILILARY ENDOPROSTHESIS | FGE | Unknown | W.L. Gore & Associates, Inc. Medical Products Div. | accessdata.fda.gov |
| April 2, 2007 | K070644 | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS | FTL | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| December 7, 2005 | K053200 | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | FTL | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| December 22, 2004 | K043056 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | FTL | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| July 21, 2004 | K041423 | VIABIL BILIARY ENDOPROSTHESIS | FGE | Unknown | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| July 29, 1999 | K992189 | GORE-TEX DUALMESH BIOMATERIAL | FTL | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| October 25, 1996 | K963619 | GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES | FTL | 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 |
|---|---|---|---|---|---|---|
| May 12, 1986 | P820083 | GORE-TEX(R) EXPANDED PTFE SUTURE | GAW | 24 | August 27, 1998 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 3, 2024 | 94976 | Class II | Ongoing | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25 | Devices were labeled with an expiration date of four years and ten days rather than the validated two years. | accessdata.fda.gov |
| January 19, 2024 | 93882 | Class II | Ongoing | GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes | Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis | accessdata.fda.gov |
| April 5, 2021 | 87699 | Class II | Terminated | GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the | The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length. | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Absorbable, Abdominal Hernia
- All makers of Mesh, Surgical, Absorbable, Staple Line Reinforcement
- All makers of Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
- All makers of Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
- All makers of Mesh, Surgical, Polymeric
- All makers of Stents, Drains And Dilators For The Biliary Ducts
Updated August 6, 2024. 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.