# K140116: Restorelle Y Contour Mesh

- Pathway: 510(k) (Special)
- Applicant: Coloplast A/S
- Decided: Feb 12, 2014 after 27 days
- Product code: OTO (Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed)
- 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: 13 generations back to K931386 (1993). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123914: Restorelle Y Contour, Coloplast A/S (2013) Summary page 1.

## Most influential descendants
- K173501: Meridian Vaginal Positioning System (VPS) (2018), 0 descendants of its own

## Indications for use
Restorelle Y Contour Polypropylene Mesh device is indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Source page: https://510kreport.com/device/K140116
Methodology: https://510kreport.com/methodology