# K050311: Atrium Medical Corporation C-Qur Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Atrium Medical Corp.
- Decided: Mar 31, 2006 after 416 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K100076: Atrium C-Qur Ovt Mesh (2010), 1 descendant of its own
- 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-1937-2013: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
- Jul 19, 2013 · Class II · Z-1936-2013: 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
Atrium C-QURTM Mesh is indicated for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a supportive material.

Source page: https://510kreport.com/device/K050311
Methodology: https://510kreport.com/methodology