# K221487: NEOVEIL Staple Line Reinforcement

- Pathway: 510(k) (Special)
- Applicant: Gunze Limited
- Decided: Aug 26, 2022 after 95 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: 9 generations back to K842066 (1985). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130997: Neoveil, Gunze Limited (2013) Summary page 4.

## Indications for use
NEOVEIL® Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. NEOVEIL® Staple Line Reinforcement can be used for reinforcement of staple lines during lung resection, liver resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.

Source page: https://510kreport.com/device/K221487
Methodology: https://510kreport.com/methodology