# K253657: Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads

- Pathway: 510(k) (Traditional)
- Applicant: Covidien (Part of Medtronic)
- Decided: Apr 10, 2026 after 141 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K842066 (1985). 91 ancestors in all.
No later device cites it as a predicate yet.
4 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202864: Tri-Staple 2.0 Reloads, Covidien (2020) Summary page 5.
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers, Covidien, Formerly US Surgical A Divison of Tyco H (2011) Summary page 5.
- K222641: Signia™ Small Diameter Reloads Including Regular (Round) Tip Version, Covidien (2022) Summary page 5.
- K241629: ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler  (ECH45S); Echelon 3000 45mm Long Stapler  (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler  (ECH60S); Echelon 3000 60mm Long Stapler  (ECH60L), Ethicon Endo-Surgery, LLC (2024) Summary page 5.
- K141952: Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads for Advanced, Ethicon Endo-Surgery, Inc. (2014) Summary page 5.

## Indications for use
The Tri‑Staple™ 2.0 reloads are indicated for use in abdominal, urologic, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. The Tri‑Staple™ 2.0 curved tip reloads can be used to blunt dissect or separate target tissue from other tissue. The Endo GIA™ Ultra universal short, Endo GIA™ Ultra universal and Endo GIA™ Ultra universal XL staplers and Endo GIA™ reloads with Tri‑Staple™ technology are indicated for use in abdominal, urologic, gynecologic, pediatric, and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. The Endo GIA™ Ultra universal short, Endo GIA™ Ultra universal and Endo GIA™ Ultra universal XL staplers when used with the Endo GIA™ curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue. The Signia™ small diameter reloads are indicated for use in abdominal, urologic, gynecologic, pediatric and thoracic surgery for resection and transection of vasculature using gray reloads and thin tissue and vasculature using white reloads.

Source page: https://510kreport.com/device/K253657
Methodology: https://510kreport.com/methodology