# K022350: Bard Crurasoft Patch, Models 0116003 & 0116001

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 23, 2002 after 35 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
Longest line of descent: 1 generation back to K001789 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001789: Seamguard Staple Line Reinforcement Material, W. L. Gore & Associates, Inc. (2000)
- (no number) Bard Composix E/X mesh: named in the summary without a submission number
- (no number) PTFE mesh: named in the summary without a submission number

## Indications for use
The Bard CruraSoft Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of chest wall defects and hernias, including diaphragmatic/hiatal hernias.

Source page: https://510kreport.com/device/K022350
Methodology: https://510kreport.com/methodology