FDA Product Code GDW: Staple, Implantable

Tissue approximation and fixation during surgery requires reliable mechanical solutions. FDA product code GDW covers implantable surgical staples used in soft tissue repair.

These metal staples close wound edges, approximate tissue layers, or anchor soft tissue to bone in procedures where sutures alone may be insufficient. They are used in general surgery, orthopedics, and plastic surgery.

GDW devices are Class II medical devices, regulated under 21 CFR 878.4750 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include United States Surgical, A Division of Tyco Healthc, Covidien and Ethicon Endo-Surgery, LLC.