Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

W. L. Gore & Associates, Inc.

FDA 510(k) & PMA Approved Devices — 163 products

Total Devices163
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K250410 GORE® Tri-Lobe Balloon CatheterDQY2025-06-02 View
510(k) K240083 GORE® PROPATEN® Vascular GraftDSY2024-03-01 View
510(k) K232312 GORE® PROPATEN® Vascular GraftDSY2024-01-09 View
510(k) K233551 GORE® ACUSEAL Vascular GraftDSY2023-12-19 View
510(k) K231505 GORE® ACUSEAL Vascular GraftDSY2023-06-23 View
510(k) K222919 GORE® ENFORM BiomaterialOXF2022-12-19 View
510(k) K191773 GORE BIO-A Tissue ReinforcementOWT2019-07-31 View
510(k) K180919 GORE Tri-Lumen CatheterDQY2018-10-05 View
510(k) K181940 GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC2018-08-17 View
510(k) K173333 GORE ENFORM BiomaterialOXF2018-04-05 View
510(k) K172567 GORE Molding and Occlusion Balloon CatheterMJN2018-01-31 View
510(k) K163576 GORE SYNECOR Preperitoneal BiomaterialFTL2017-05-11 View
510(k) K170740 GORE VIABIL Short Wire Biliary EndoprosthesisFGE2017-05-08 View
510(k) K163217 GORE BIO-A Tissue ReinforcementOXF2017-02-10 View
510(k) K160254 GORE DrySeal Flex Introducer SheathDYB2016-05-12 View
510(k) K131658 GORE SEAMGUARD REINFORCEMENTOXC2013-09-06 View
510(k) K130215 GORE ACUSEAL VASCULAR GRAFTDSY2013-04-09 View
510(k) K123156 GORE FLOW REVERSAL SYSTEM MODEL GFRS073NTE2012-12-13 View
510(k) K121234 GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATINGDYB2012-11-20 View
510(k) K120428 GORE DRYSEAL SHEATHDYB2012-04-20 View
↑