# K122794: Upsylon Y Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 18, 2012 after 97 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). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103426: Lite Pelvic Floor Repair Kits, Boston Scientific Corp (2011) Summary page 1.
- K112322: Restorelle Polypropylene Y Mesh, Coloplast A/S (2012)

## Indications for use
The Upsylon Y mesh is intended for use as a 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/K122794
Methodology: https://510kreport.com/methodology