# K141560: Ethicon Physiomesh Open Flexible Composite Mesh Device

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Oct 23, 2014 after 133 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: 6 generations back to K971745 (1997). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093932: Ethicon Physiomesh, Flexible Composite Mesh, Ethicon GmbH (2010) Summary page 4.
- K101920: Ventrio ST Hernia Patch, C.R. Bard, Inc. (2011) Summary page 4.
- K110816: Parietex Optimized Composite Mesh (Pco-Osx References), Sofradim Production (2011) Summary page 4.

## Indications for use
ETHICON PHYSIOMESH™ Open may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Source page: https://510kreport.com/device/K141560
Methodology: https://510kreport.com/methodology