Soft Tissue Patch Plus, Dualmesh Plus, Mycromesh Plus, Dualmesh Plus with Holes

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

510(k) Number

K981051 ↗

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 this mesh designed for, and how does the texture variation help in those applications?

  This mesh is designed for hernia repair, soft tissue deficiency reconstruction, and temporary fascial defect bridging. The variants—such as DualMesh Plus (dual-surface design), Mycromesh Plus (fine-textured surface), and DualMesh Plus with holes—are engineered to modulate tissue ingrowth and adhesion properties. For example, the dual-surface design may reduce friction against surrounding tissues, while the porous or perforated variants (like DualMesh Plus with holes) may promote better integration with soft tissues, depending on the surgical need.

• Is this mesh reusable, or is it intended for single-use only? How should it be stored if unused?

  The mesh is intended for single-use only in surgical settings, as explicitly stated in the device description. While storage conditions are not detailed in the regulatory submission, single-use medical devices like this are typically stored in a clean, dry environment—protected from moisture, extreme temperatures, and direct sunlight—until use. Always follow manufacturer instructions for optimal shelf life.

• What materials is this mesh made from, and how does that affect its performance in surgery?

  The mesh is manufactured from Gore-Tex biomaterials, a proprietary polymeric material known for its biocompatibility and durability. These materials are designed to resist degradation while supporting tissue integration over time. The texture variations (e.g., dual-surface, microporous, or perforated designs) further influence how the mesh interacts with surrounding tissues, balancing strength, flexibility, and ingrowth characteristics for specific surgical applications.

• Are there different sizes or configurations available, and how do I determine which one is right for my procedure?

  Yes, the mesh comes in multiple sizes and configurations, including DualMesh Plus, Mycromesh Plus, and DualMesh Plus with holes, each tailored for specific surgical needs. The exact sizing and selection depend on the anatomical defect size, tissue type, and clinical indication (e.g., hernia repair vs. soft tissue reconstruction). Consult the manufacturer’s product catalog or surgical guidelines for matching the correct size to your procedure, as these details are not specified in the regulatory data provided.

• Can this mesh be used in patients who require MRI scans after surgery, or are there any MRI-related concerns?

  The regulatory submission does not specify MRI safety data for this mesh, meaning its compatibility with MRI procedures is not confirmed. If MRI imaging is anticipated post-surgery, verify compatibility with the manufacturer or use alternative imaging modalities until further information is available. Always prioritize patient safety when considering imaging with untested devices.