# K233402: Bard 3DMax Mesh

- Pathway: 510(k) (Special)
- Applicant: Davol Inc., Subsidiary of C. R. Bard, Inc.
- Decided: Nov 1, 2023 after 28 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 K081010 (2008). 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)
- K081010: Bard 3DMAX Mesh, Davol Inc., Sub. C. R. Bard, Inc. (2008) Summary page 6.

## Indications for use
Bard® 3DMax™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias.

Source page: https://510kreport.com/device/K233402
Methodology: https://510kreport.com/methodology