# K093932: Ethicon Physiomesh, Flexible Composite Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon GmbH
- Decided: Apr 9, 2010 after 108 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 K031925 (2003). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031925: Proceed Trilaminate Surgical Mesh, ETHICON, Inc. (2003) Summary page 1.
- K060713: Proceed Surgical Mesh, ETHICON, Inc. (2006) Summary page 1.
- K071249: Ultrapro* Hernia System, Models Uhsl, Uhsm, Uhsov, ETHICON, Inc. (2007) Summary page 1.
- K033337: Ultrapro Mesh, ETHICON, Inc. (2004) Summary page 1.

## Most influential descendants
- K152609: GORE SYNECOR Biomaterial (2015), 3 descendants of its own
- K173333: GORE ENFORM Biomaterial (2018), 1 descendant of its own
- K222919: GORE® ENFORM Biomaterial (2022), 0 descendants of its own
- K163576: GORE SYNECOR Preperitoneal Biomaterial (2017), 0 descendants of its own
- K141560: Ethicon Physiomesh Open Flexible Composite Mesh Device (2014), 0 descendants of its own

## Indications for use
ETHICON PHYSIOMESH™ 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/K093932
Methodology: https://510kreport.com/methodology