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, Ethicon Endo-Surgery, LLC and Fengh Medical Co., Ltd..
FDA 510(k) Cleared Staple, Implantable Devices (Product Code GDW)
About Product Code GDW - Regulatory Context
510(k) Submission Activity
282 total 510(k) submissions under product code GDW since 1976, with 282 receiving FDA clearance (average review time: 95 days).
Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.
FDA Review Time
FDA review times for GDW submissions have been consistent, averaging 102 days recently vs 95 days historically.
GDW devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →