# K033376: Ugytex Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: Jan 15, 2004 after 85 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 K991400 (1999). 3 ancestors in all.
70 later devices descend from it; 3 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002699: Parietex Composite (Pco) Mesh, Medical Device Consultants, Inc. (2001) Summary page 1.
- K991400: Parietene Polypropylene Mesh, Sofradim Production (1999) Summary page 1.
- K013718: Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair, Gynecare, A Div. of Ethicon, Inc. (2002) Summary page 1.

## Most influential descendants
- K040998: Modification to Parietex Composite (Pco) Mesh (2004), 61 descendants of its own
- K050187: Parietex Composite Pco-OS and Pco-OB Meshes (2005), 31 descendants of its own
- K073287: Prevadh Mesh (2008), 17 descendants of its own
- K081126: Parietex Composite Mono PM Mesh (2008), 15 descendants of its own
- K081050: Parietex Progrip Mesh (2008), 15 descendants of its own

## Indications for use
The UGYTEX Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

Source page: https://510kreport.com/device/K033376
Methodology: https://510kreport.com/methodology