W.L. Gore & Associates, Inc. - FDA 510(k) Cleared Devices

W.L. Gore & Associates, Inc. is a global materials science company specializing in advanced medical devices. The company operates with a manufacturing facility in McHenry, US.

The company has received 148 FDA 510(k) clearances from 163 total submissions since its first clearance in 1980. Cardiovascular devices represent a dominant category, including vascular grafts and balloon catheters. Recent clearances also span general surgery, plastic surgery, and gastroenterology applications. The latest FDA 510(k) clearance in 2025 reflects ongoing regulatory activity.

W.L. Gore & Associates develops implantable and surgical products built on proprietary fluoropolymer technology. Core product lines include vascular grafts, tissue reinforcement materials, and endoprostheses. The company's devices are used in cardiovascular surgery, wound closure, and minimally invasive procedures.

Explore the complete list of device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by W. L. Gore & Associates, Inc. as regulatory consultant.