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 Covidien and Ethicon Endo-Surgery, LLC.
List of Staple, Implantable devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Staple, Implantable devices (product code GDW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →