# K082216: TBD Ethicon Mesh

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Sep 5, 2008 after 30 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: 10 generations back to K931386 (1993). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013718: Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair, Gynecare, A Div. of Ethicon, Inc. (2002) Summary page 1.
- K071512: Gynecare Prolift +M* Pelvic Floor Repair Systems, ETHICON, Inc. (2008) Summary page 1.

## Most influential descendants
- K113205: Artisyn Y-Shaped Mesh (2012), 0 descendants of its own

## Indications for use
ETHICON 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/K082216
Methodology: https://510kreport.com/methodology