# K192330: EEA Circular Stapler with Tri-Staple Technology

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Jan 23, 2020 after 149 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: 3 generations back to K024275 (2003). 3 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172361: EEA Circular Stapler with Tri-Staple Technology, Covidien (2018) Summary page 4.
- K062850: Autosuture Circular Eea Surgical Staplers, United States Surgical, A Division of Tyco Healthc (2006) Summary page 4.

## Most influential descendants
- 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
- K221629: Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) (2023), 2 descendants of its own
- K221771: EEA Circular Stapler with Tri-Staple Technology (2022), 2 descendants of its own
- K253527: Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K192330
Methodology: https://510kreport.com/methodology