# K253125: Parietene™ Flat Sheet Mesh

- Pathway: 510(k) (Special)
- Applicant: Medtronic - Sofradim Production
- Decided: Oct 24, 2025 after 29 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: 7 generations back to K991400 (1999). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140941: Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet Mesh, Sofradim Production (2014) Summary page 5.

## Indications for use
Parietene™ flat Sheet Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair.

Source page: https://510kreport.com/device/K253125
Methodology: https://510kreport.com/methodology