Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
W. L. Gore & Associates, Inc. · Predicate Candidate Screening
163 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
234 days90th percentile
163clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250410 | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | 2025-06-02 | 109 | 0 |
| K240083 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024-03-01 | 50 | 0 |
| K232312 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024-01-09 | 160 | 0 |
| K233551 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023-12-19 | 46 | 1 |
| K231505 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023-06-23 | 30 | 0 |
| K191773 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2019-07-31 | 29 | 0 |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | W. L. Gore & Associates, Inc. | 2018-08-17 | 29 | 0 |
| K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | 2018-04-05 | 164 | 0 |
| K163576 | GORE SYNECOR Preperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2017-05-11 | 143 | 0 |
| K170740 | GORE VIABIL Short Wire Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-08 | 59 | 3 |
| K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017-02-10 | 86 | 0 |
| K160254 | GORE DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | 2016-05-12 | 101 | 0 |
| K152609 | GORE SYNECOR Biomaterial | W. L. Gore & Associates, Inc. | 2015-12-11 | 88 | 0 |
| K150551 | GORE SEAMGUARD Reinforcement | W. L. Gore & Associates, Inc. | 2015-03-30 | 26 | 0 |
| K132397 | GORE BIO-A WOUND MATRIX | W. L. Gore & Associates, Inc. | 2014-05-07 | 279 | 0 |
| K131658 | GORE SEAMGUARD REINFORCEMENT | W. L. Gore & Associates, Inc. | 2013-09-06 | 92 | 0 |
| K130215 | GORE ACUSEAL VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 2013-04-09 | 70 | 0 |
| K123156 | GORE FLOW REVERSAL SYSTEM MODEL GFRS073 | W. L. Gore & Associates, Inc. | 2012-12-13 | 65 | 0 |
| K121234 | GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING | W. L. Gore & Associates, Inc. | 2012-11-20 | 210 | 0 |
| K120428 | GORE DRYSEAL SHEATH | W. L. Gore & Associates, Inc. | 2012-04-20 | 67 | 0 |
| K103500 | GORE EMBOLIC FILTER | W. L. Gore & Associates, Inc. | 2011-05-23 | 175 | 0 |
| K093791 | GORE DRYSEAL SHEATH | W. L. Gore & Associates, Inc. | 2010-03-22 | 102 | 0 |
| K083266 | GORE BIO-A FISTULA PLUG | W. L. Gore & Associates, Inc. | 2009-03-27 | 142 | 0 |
| K083300 | GORE FLOW REVERSAL SYSTEM | W. L. Gore & Associates, Inc. | 2009-02-04 | 86 | 0 |
| K081799 | GORE TRI-LOBE BALLOON CATHETER | W. L. Gore & Associates, Inc. | 2008-10-03 | 100 | 0 |
| K082356 | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE | W. L. Gore & Associates, Inc. | 2008-08-28 | 10 | 0 |
| K081069 | GORE INFINIT MESH | W. L. Gore & Associates, Inc. | 2008-05-30 | 45 | 0 |
| K070770 | GORE BALLOON SHEATH | W. L. Gore & Associates, Inc. | 2007-06-29 | 101 | 0 |
| K070644 | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCUL | W. L. Gore & Associates, Inc. | 2007-04-02 | 25 | 0 |
| K063435 | GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERI | W. L. Gore & Associates, Inc. | 2006-11-28 | 15 | 0 |
| K062161 | GORE PROPATEN VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 2006-11-09 | 104 | 0 |
| K061727 | GORE PRECLUDE VESSEL GUARD | W. L. Gore & Associates, Inc. | 2006-08-07 | 49 | 0 |
| K053200 | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL | W. L. Gore & Associates, Inc. | 2005-12-07 | 21 | 1 |
| K051267 | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERA | W. L. Gore & Associates, Inc. | 2005-06-15 | 30 | 0 |
| K043056 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATER | W. L. Gore & Associates, Inc. | 2004-12-22 | 47 | 0 |
| K043081 | GORE POLYPROPYLENE HERNIA MESH | W. L. Gore & Associates, Inc. | 2004-12-22 | 44 | 0 |
| K041423 | VIABIL BILIARY ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | 2004-07-21 | 54 | 0 |
| K033670 | GORE TRI-LOBE BALLOON CATHETER | W. L. Gore & Associates, Inc. | 2004-05-05 | 163 | 0 |
| K033671 | GORE BIOABSORBABLE MESH | W. L. Gore & Associates, Inc. | 2003-12-31 | 37 | 0 |
| K032865 | GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATER | W. L. Gore & Associates, Inc. | 2003-11-28 | 77 | 0 |
| K032168 | GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL | W. L. Gore & Associates, Inc. | 2003-08-15 | 30 | 0 |
| K032073 | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE | W. L. Gore & Associates, Inc. | 2003-08-13 | 41 | 0 |
| K031089 | GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY | W. L. Gore & Associates, Inc. | 2003-05-08 | 31 | 0 |
| K030782 | SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | W. L. Gore & Associates, Inc. | 2003-04-21 | 41 | 0 |
| K024178 | VIATORR ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | 2003-03-07 | 79 | 0 |
| K014215 | VIABIL BILIARY ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | 2002-12-19 | 363 | 0 |
| K023811 | MODIFICATION TO VIABAHN ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | 2002-12-10 | 25 | 0 |
| K023679 | GORE 3.0T TORSO ARRAY | W. L. Gore & Associates, Inc. | 2002-11-18 | 17 | 0 |
| K021477 | PRECLUDE MVP DURA SUBSTITUTE | W. L. Gore & Associates, Inc. | 2002-11-08 | 184 | 0 |
| K022782 | DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL | W. L. Gore & Associates, Inc. | 2002-09-10 | 19 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda