Gore-Tex Soft Tissue Patch

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K951700 ↗

FDA Product Code

FTL

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

  Class III

  CE/MDR MDR 732278 Expiring Valid to Feb 2027

• GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface

  Class III

  CE/MDR MDR 731181 Active Valid to Jul 2031

• GORE-TEX® Stretch Vascular Graft

  Class III

  CE/MDR MDR 732281 Active Valid to Jul 2031

• GORE® EXCLUDER® Iliac Branch Endoprosthesis

  Class III

  CE/MDR MDR 731176 Active Valid to Jul 2031

• GORE® DrySeal Flex Introducer Sheath

  Class III

  CE/MDR MDR 764343 Active Valid to Apr 2028

• GORE® EXCLUDER® Conformable AAA Endoprosthesis

  Class III

  CE/MDR MDR 731175 Active Valid to Jul 2031

See all devices from W. L. Gore & Associates, Inc. →

• What types of surgical procedures is the Gore-Tex Soft Tissue Patch primarily intended to support, and why is it designed this way?

  The Gore-Tex Soft Tissue Patch is primarily designed for use in plastic surgery procedures, where it reinforces and supports soft tissue to aid in wound closure and maintain structural integrity. Its construction from expanded polytetrafluoroethylene (ePTFE) provides a durable, flexible material that mimics the properties of natural tissue, making it ideal for applications requiring long-term support and integration with surrounding tissues.

• How should the Gore-Tex Soft Tissue Patch be stored to ensure it remains sterile and intact before use?

  The Gore-Tex Soft Tissue Patch must be stored according to the manufacturer’s guidelines to maintain sterility and integrity. Since it is supplied sterile and intended for single-use, it should be kept in its original packaging, protected from moisture, heat, and physical damage. Avoid exposing it to conditions that could compromise its sterile barrier or structural properties.

• Are there multiple sizes available for the Gore-Tex Soft Tissue Patch, and how does this benefit surgeons?

  Yes, the Gore-Tex Soft Tissue Patch is available in various sizes, allowing surgeons to select the appropriate dimensions for specific anatomical requirements. This versatility ensures a better fit for different surgical sites, improving the patch’s effectiveness in reinforcing tissue and reducing the risk of complications like migration or exposure.

• Is the Gore-Tex Soft Tissue Patch reusable, or is it designed for single-use only?

  The Gore-Tex Soft Tissue Patch is explicitly designed for single-use only. Its sterile packaging and intended surgical application—where contamination risks are high—preclude reuse. Reusing it could compromise patient safety by introducing infection or compromising structural integrity.

• What regulatory pathways has the Gore-Tex Soft Tissue Patch followed, and what does that mean for its use in clinical settings?

  The Gore-Tex Soft Tissue Patch has undergone FDA 510(k) clearance and complies with the Medical Device Directive (MDD). This means it has been evaluated for safety and effectiveness by regulatory authorities and is classified as a Class II medical device under FDA regulations. Clinicians can rely on its established regulatory history, though they should always follow local guidelines and institutional protocols for surgical mesh use.