# K260196: ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: May 11, 2026 after 109 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: 4 generations back to K940967 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201280: Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed, Ethicon Endo-Surgery, LLC (2020) Summary page 5.

## Indications for use
The ETHICON™ Circular Staplers have application throughout the alimentary tract for end-to-end, end-to side, and side-to-side anastomoses.

Source page: https://510kreport.com/device/K260196
Methodology: https://510kreport.com/methodology