Company · US
W. L. Gore & Associates, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2025. Name variants (Inc, Corp, punctuation) are merged.
166510(k) clearances (0 in 12 months)
32recalls (4 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 38 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 27 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 13 |
| MLV | Transcatheter Septal Occluder | 11 |
| DYB | Introducer, Catheter | 8 |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 8 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 8 |
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | 7 |
| LYC | Bone Grafting Material, Synthetic | 5 |
| NPK | Barrier, Synthetic, Intraoral | 5 |
| MOS | Coil, Magnetic Resonance, Specialty | 4 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 4 |
| DQY | Catheter, Percutaneous | 3 |
| FWP | Prosthesis, Chin, Internal | 3 |
| GXQ | Dura Substitute | 3 |
| HRX | Arthroscope | 3 |
| JCT | Prosthesis, Tracheal, Expandable | 3 |
| OXC | Mesh, Surgical, Absorbable, Staple Line Reinforcement | 3 |
| OXD | Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement | 3 |
| PRL | Iliac Covered Stent, Arterial | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 2025 | K250410 | GORE® Tri-Lobe Balloon Catheter W. L. Gore & Associates, Inc. | DQY |
| Mar 1, 2024 | K240083 | GORE® PROPATEN® Vascular Graft W. L. Gore & Associates, Inc. | DSY |
| Jan 9, 2024 | K232312 | GORE® PROPATEN® Vascular Graft W. L. Gore & Associates, Inc. | DSY |
| Dec 19, 2023 | K233551 | GORE® ACUSEAL Vascular Graft W. L. Gore & Associates, Inc. | DSY |
| Jun 23, 2023 | K231505 | GORE® ACUSEAL Vascular Graft W. L. Gore & Associates, Inc. | DSY |
| Jul 31, 2019 | K191773 | GORE BIO-A Tissue Reinforcement W. L. Gore & Associates, Inc. | OWT |
| Aug 17, 2018 | K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement W. L. Gore & Associates, Inc. | OXC |
| Apr 5, 2018 | K173333 | GORE ENFORM Biomaterial W. L. Gore & Associates, Inc. | OXF |
| May 11, 2017 | K163576 | GORE SYNECOR Preperitoneal Biomaterial W. L. Gore & Associates, Inc. | FTL |
| May 8, 2017 | K170740 | GORE VIABIL Short Wire Biliary Endoprosthesis W. L. Gore & Associates, Inc. | FGE |
| Feb 10, 2017 | K163217 | GORE BIO-A Tissue Reinforcement W. L. Gore & Associates, Inc. | OXF |
| May 12, 2016 | K160254 | GORE DrySeal Flex Introducer Sheath W. L. Gore & Associates, Inc. | DYB |
| Dec 11, 2015 | K152609 | GORE SYNECOR Biomaterial W. L. Gore & Associates, Inc. | FTL |
| Mar 30, 2015 | K150551 | GORE SEAMGUARD Reinforcement W. L. Gore & Associates, Inc. | OXC |
| May 7, 2014 | K132397 | GORE BIO-A WOUND MATRIX W. L. Gore & Associates, Inc. | QSZ |
| Sep 6, 2013 | K131658 | GORE SEAMGUARD REINFORCEMENT W. L. Gore & Associates, Inc. | OXC |
| Apr 9, 2013 | K130215 | GORE ACUSEAL VASCULAR GRAFT W. L. Gore & Associates, Inc. | DSY |
| Dec 13, 2012 | K123156 | GORE FLOW REVERSAL SYSTEM MODEL GFRS073 W. L. Gore & Associates, Inc. | NTE |
| Nov 20, 2012 | K121234 | GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING W. L. Gore & Associates, Inc. | DYB |
| Apr 20, 2012 | K120428 | GORE DRYSEAL SHEATH W. L. Gore & Associates, Inc. | DYB |
| Mar 16, 2012 | K120480 | GORE(R) EMBOLIC FILTER W.L. Gore & Associates | NTE |
| May 23, 2011 | K103500 | GORE EMBOLIC FILTER W. L. Gore & Associates, Inc. | NTE |
| Mar 22, 2010 | K093791 | GORE DRYSEAL SHEATH W. L. Gore & Associates, Inc. | DYB |
| Mar 17, 2010 | K093934 | GORE HYBRID VASCULAR GRAFT W.L. Gore & Associates | DSY |
| Mar 27, 2009 | K083266 | GORE BIO-A FISTULA PLUG W. L. Gore & Associates, Inc. | FTL |
| Feb 4, 2009 | K083300 | GORE FLOW REVERSAL SYSTEM W. L. Gore & Associates, Inc. | NTE |
| Oct 3, 2008 | K081799 | GORE TRI-LOBE BALLOON CATHETER W. L. Gore & Associates, Inc. | DQY |
| Aug 28, 2008 | K082356 | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE W. L. Gore & Associates, Inc. | DYB |
| May 30, 2008 | K081069 | GORE INFINIT MESH W. L. Gore & Associates, Inc. | FTL |
| Jun 29, 2007 | K070770 | GORE BALLOON SHEATH W. L. Gore & Associates, Inc. | MJN |
| Apr 2, 2007 | K070644 | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS W. L. Gore & Associates, Inc. | FTL |
| Nov 28, 2006 | K063435 | GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL W. L. Gore & Associates, Inc. | FTL |
| Nov 9, 2006 | K062161 | GORE PROPATEN VASCULAR GRAFT W. L. Gore & Associates, Inc. | DSY |
| Aug 7, 2006 | K061727 | GORE PRECLUDE VESSEL GUARD W. L. Gore & Associates, Inc. | MFX |
| Dec 7, 2005 | K053202 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W.L. Gore & Associates | FTL |
| Dec 7, 2005 | K053200 | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc. | FTL |
| Jun 15, 2005 | K051267 | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE W. L. Gore & Associates, Inc. | NPK |
| Dec 22, 2004 | K043081 | GORE POLYPROPYLENE HERNIA MESH W. L. Gore & Associates, Inc. | FTL |
| Dec 22, 2004 | K043056 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc. | FTL |
| Jul 21, 2004 | K041423 | VIABIL BILIARY ENDOPROSTHESIS W. L. Gore & Associates, Inc. | FGE |
| May 5, 2004 | K033670 | GORE TRI-LOBE BALLOON CATHETER W. L. Gore & Associates, Inc. | DQY |
| Dec 31, 2003 | K033671 | GORE BIOABSORBABLE MESH W. L. Gore & Associates, Inc. | OWT |
| Nov 28, 2003 | K032865 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc. | FTL |
| Aug 15, 2003 | K032168 | GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL W. L. Gore & Associates, Inc. | FTL |
| Aug 13, 2003 | K032073 | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE W. L. Gore & Associates, Inc. | DYB |
| May 8, 2003 | K031089 | GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY W. L. Gore & Associates, Inc. | MOS |
| Apr 21, 2003 | K030782 | SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc. | FTM |
| Mar 7, 2003 | K024178 | VIATORR ENDOPROSTHESIS W. L. Gore & Associates, Inc. | JCT |
| Dec 19, 2002 | K014215 | VIABIL BILIARY ENDOPROSTHESIS W. L. Gore & Associates, Inc. | FGE |
| Dec 10, 2002 | K023811 | MODIFICATION TO VIABAHN ENDOPROSTHESIS W. L. Gore & Associates, Inc. | JCT |
Newest 50 of 166.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2026 | W L Gore & Associates, Inc. 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-ex Open, Classified |
FGE | K170740 |
| Aug 7, 2026 | W L Gore & Associates, Inc. GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. Open, Classified |
FGE | K170740 |
| Aug 7, 2026 | W L Gore & Associates, Inc. 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. Open, Classified |
FGE | K170740 |
| Jul 2, 2026 | W L Gore & Associates, Inc. GORE TAG Thoracic Branch Endoprosthesis Side Branch Component
Catalog Numbers (by Region)
United States (includes Puerto Rico) and Canada:
TSB080806A, TSB081006A, TSB081206A,
TSB081506A, TSB081706A, T Open, Classified |
MIH | None listed |
| Oct 2, 2025 | W L Gore & Associates, Inc. GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, Open, Classified |
DSY | K233551 |
| Aug 30, 2024 | W L Gore & Associates, Inc. Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers:
United States:
BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, B Open, Classified |
PRL | None listed |
| Aug 30, 2024 | W L Gore & Associates, Inc. Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers:
United States:
BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A
BXB053901A BXB05390 Open, Classified |
PRL | None listed |
| Aug 6, 2024 | W.L. Gore & Associates, Inc. GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25; Open, Classified |
FTL | K053200 |
| Feb 22, 2024 | W.L. Gore & Associates, Inc. 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 Open, Classified |
FGE | K170740 |
| Feb 1, 2023 | W L Gore & Associates, Inc. GORE CARDIOFORM Septal Occluder, REF: GSX0030A Open, Classified |
MLV | None listed |
| Oct 26, 2022 | W L Gore & Associates, Inc. GORE CARDIOFORM ASD Occluder. cardiovascular implant. Open, Classified |
MLV | None listed |
| Sep 7, 2021 | W L Gore & Associates, Inc. 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: Open, Classified |
PRL | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948
*Not distributed within t Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128
*Not distributed within Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111
*Not distributed within Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661
*Not distributed within t Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647
*Not distributed within t Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630
*Not distributed within t Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025
*Not distributed within t Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018 Open, Classified |
MLV | None listed |
| Sep 2, 2021 | W L Gore & Associates, Inc. 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 Open, Classified |
MLV | None listed |
| Jul 12, 2021 | W. L. Gore & Associates Inc. Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489 Open, Classified |
MJN | K172567 |
| May 12, 2021 | W L Gore & Associates, Inc. Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers:
HPT060015 UDI: (01)00733132606368
HPT060015A UDI: Open, Classified |
DSY | K062161 |
| May 12, 2021 | W L Gore & Associates, Inc. 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: Open, Classified |
DSY | K062161 |
| Apr 5, 2021 | W.L. Gore & Associates, Inc. GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignan Terminated |
FGE | K081184 |
| Sep 9, 2020 | W L Gore & Associates, Inc. GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System Open, Classified |
MIH | None listed |
| Sep 9, 2020 | W L Gore & Associates, Inc. GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System Open, Classified |
MIH | None listed |
| May 20, 2020 | W L Gore & Associates, Inc. Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta. Terminated |
MIH | None listed |
| Jan 6, 2020 | W. L. Gore & Associates Inc. GORE EXCLUDER Iliac Branch Endoprosthesis
(IBE) Terminated |
MIH | None listed |
| Jan 6, 2020 | W. L. Gore & Associates Inc. GORE EXCLUDER AAA Endoprosthesis Terminated |
MIH | None listed |
| Nov 18, 2019 | W. L. Gore & Associates Inc. Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ. Terminated |
DYB | K160254 |
| Oct 25, 2017 | W L Gore & Associates, Inc. GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE.
The GORE TAG Thoracic Endoprosthesis is intended
for endovascular repair of all lesions of the descending
thoracic aorta. Terminated |
MIH | None listed |