W. L. Gore & Associates, Inc. FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
GORE® Tri-Lobe Balloon Catheter510(k)Jun 2, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 2, 2025
GORE® PROPATEN® Vascular Graft510(k)Mar 1, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 1, 2024
GORE® PROPATEN® Vascular Graft510(k)Jan 9, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 9, 2024
GORE® ACUSEAL Vascular Graft510(k)Dec 19, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 19, 2023
GORE® ACUSEAL Vascular Graft510(k)Jun 23, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jun 23, 2023