# K140533: Galaflex Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Tepha, Inc.
- Decided: May 21, 2014 after 78 days
- Product code: OOD (Surgical Film)
- 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: 11 generations back to K921895 (1992). 60 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113723: Tephaflex Mesh, Tepha, Inc. (2012) Summary page 1.
- K111946: Tephaflex Mesh, Tepha, Inc. (2011) Summary page 1.
- K101287: Tephaflex Composite Mesh, Tepha, Inc. (2010) Summary page 1.
- K070894: Tephaflex Surgical Mesh, Tepha, Inc. (2007) Summary page 1.
- K123128: Seri Surgical Scaffold, Allergan (2013) Summary page 1.

## Most influential descendants
- K161092: GalaSHAPE 3D (2016), 1 descendant of its own
- K202425: SurgiLattice scaffold (2021), 0 descendants of its own
- K162922: GalaFORM 3D (2017), 0 descendants of its own

## Indications for use
GalaFLEX mesh is indicated for use as a transitory scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction.

Source page: https://510kreport.com/device/K140533
Methodology: https://510kreport.com/methodology