# K172361: EEA Circular Stapler with Tri-Staple Technology

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Feb 16, 2018 after 196 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K024275 (2003). 2 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062850: Autosuture Circular Eea Surgical Staplers, United States Surgical, A Division of Tyco Healthc (2006) Summary page 4.

## Most influential descendants
- K192330: EEA Circular Stapler with Tri-Staple Technology (2020), 8 descendants of its own
- K202507: EEA Circular Stapler with Tri-Staple Technology (2021), 5 descendants of its own
- K221005: EEA Circular Stapler with Tri-Staple Technology (2022), 4 descendants of its own
- K182475: Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) (2019), 3 descendants of its own
- K221629: Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) (2023), 2 descendants of its own

## Recalls of this device
- Aug 17, 2018 · Class II · Z-0070-2019: The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove th

## Indications for use
The EEA'M circular stapler with Tri-Staple'M technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

Source page: https://510kreport.com/device/K172361
Methodology: https://510kreport.com/methodology