Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads

These are surgical staple reloads (Tri-Staple 2.0, Endo GIA with Tri-Staple technology, Endo GIA Gray Articulating, and Signia Small Diameter) that place staggered rows of titanium staples while simultaneously dividing tissue. They are indicated for use in abdominal, urologic, gynecologic, pediatric, and thoracic surgery for resection, transection, creation of anastomosis, and vascular procedures.

Except for the newly added urologic indication, the subject devices are identical to their primary predicate devices in intended use, material, design, and operational principles. They place titanium staples in various heights (2.0 mm to 5.0 mm) depending on reload selection, with three or two staggered rows on either side of the cut line, and feature curved-tip options for tissue dissection and manipulation.

Not stated in this summary.

The subject devices are substantially equivalent to predicate devices K202864, K111825, K222641, K241629, and K141952 because they share identical intended use, materials, design, and operational principles. The only modification is the addition of a urologic indication, supported by real-world evidence, post-market clinical follow-up data, and published literature demonstrating safe and effective use in urologic procedures such as nephrectomy, prostatectomy, and cystectomies.