# K221343: ECHELON ENDOPATH Staple Line Reinforcement

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Sep 16, 2022 after 130 days
- Product code: OXC (Mesh, Surgical, Absorbable, Staple Line Reinforcement)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K842066 (1985). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190937: Echelon Endopath Staple Line Reinforcement, Ethicon Endo-Surgery, LLC (2019) Summary page 4.

## Most influential descendants
- K252906: ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (2026), 0 descendants of its own

## Indications for use
ECHELON ENDOPATH Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. ECHELON ENDOPATH Staple Line Reinforcement can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, and colorectal procedures.

Source page: https://510kreport.com/device/K221343
Methodology: https://510kreport.com/methodology