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W. L. Gore & Associates Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
166
Inspections
7
Compliance Actions
0

Known Names

w. l. gore and associates, w l gore and associates

Recent Recalls

NumberClassProductDate
Z-2340-2021Class IIGore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 July 12, 2021
Z-0996-2020Class IIGORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)January 6, 2020
Z-0995-2020Class IIGORE¿ EXCLUDER¿ AAA EndoprosthesisJanuary 6, 2020
Z-1962-2020Class IIGore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on November 18, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K250410GORE® Tri-Lobe Balloon CatheterJune 2, 2025
K240083GORE® PROPATEN® Vascular GraftMarch 1, 2024
K232312GORE® PROPATEN® Vascular GraftJanuary 9, 2024
K233551GORE® ACUSEAL Vascular GraftDecember 19, 2023
K231505GORE® ACUSEAL Vascular GraftJune 23, 2023
K222919GORE® ENFORM BiomaterialDecember 19, 2022
K191773GORE BIO-A Tissue ReinforcementJuly 31, 2019
K180919GORE Tri-Lumen CatheterOctober 5, 2018
K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementAugust 17, 2018
K173333GORE ENFORM BiomaterialApril 5, 2018
K172567GORE Molding and Occlusion Balloon CatheterJanuary 31, 2018
K163576GORE SYNECOR Preperitoneal BiomaterialMay 11, 2017
K170740GORE VIABIL Short Wire Biliary EndoprosthesisMay 8, 2017
K163217GORE BIO-A Tissue ReinforcementFebruary 10, 2017
K160254GORE DrySeal Flex Introducer SheathMay 12, 2016
K152609GORE SYNECOR BiomaterialDecember 11, 2015
K150551GORE SEAMGUARD ReinforcementMarch 30, 2015
K132397GORE BIO-A WOUND MATRIXMay 7, 2014
K131658GORE SEAMGUARD REINFORCEMENTSeptember 6, 2013
K130215GORE ACUSEAL VASCULAR GRAFTApril 9, 2013