# K251557: Bard® Mesh; Bard® Mesh Pre-Shaped

- Pathway: 510(k) (Special)
- Applicant: Davol, Inc.
- Decided: Jun 12, 2025 after 22 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard® Mesh; Bard® Mesh Pre-Shaped: named in the summary without a submission number

## Indications for use
Bard® Mesh is indicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects. Bard® Mesh Pre-shaped is indicated for the repair of inguinal hernia defects.

Source page: https://510kreport.com/device/K251557
Methodology: https://510kreport.com/methodology