# K172395: Duatene bilayer mesh

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: Feb 1, 2018 after 177 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 K984220 (1999). 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)
- K984220: Modification of Prolene (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh, ETHICON, Inc. (1999) Summary page 4.

## Indications for use
Duatene™ Bilayer Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. It is indicated for the open repair of groin hernia defects.

Source page: https://510kreport.com/device/K172395
Methodology: https://510kreport.com/methodology