# K100076: Atrium C-Qur Ovt Mesh

- Pathway: 510(k) (Special)
- Applicant: Atrium Medical Corp.
- Decided: Jan 26, 2010 after 14 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K050311 (2006). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050311: Atrium Medical Corporation C-Qur Mesh, Atrium Medical Corp. (2006) Summary page 1.

## Most influential descendants
- K151386: C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic (2015), 0 descendants of its own

## Recalls of this device
- Jul 19, 2013 · Class II · Z-1939-2013: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

## Indications for use
The Atrium C-Qur' OVT Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material.

Source page: https://510kreport.com/device/K100076
Methodology: https://510kreport.com/methodology