# K130997: Neoveil

- Pathway: 510(k) (Traditional)
- Applicant: Gunze Limited
- Decided: Nov 15, 2013 after 219 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). 44 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043056: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material, W. L. Gore & Associates, Inc. (2004) Summary page 1.
- K120506: Parietex Composite Ventral Patch, Sofradim Production (2012) Summary page 1.
- K131969: Symbotex (TM) Composite Mesh, Sofradim Production (2013). Cleared while this submission was under review Summary page 2.
- K040415: Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line Reinforcement, Synovis Surgical Innovations (2004) Summary page 1.

## Most influential descendants
- K133938: Endo Gia Reinforced Reload with Tri-Staple Technology (2014), 1 descendant of its own
- K221487: NEOVEIL Staple Line Reinforcement (2022), 0 descendants of its own
- K173270: Tri-Staple 2.0 Reinforced Reload (2018), 0 descendants of its own

## Indications for use
NEOVEILTh is indicated for use in surgical procedures in which soft tissue transection or resection with staple or suture line reinforcement is needed. NEOVEILM can be used for reinforcement of suture or 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/K130997
Methodology: https://510kreport.com/methodology