# K150016: Vertessa Lite

- Pathway: 510(k) (Traditional)
- Applicant: Caldera Medical, Inc.
- Decided: Apr 6, 2015 after 91 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). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123337: Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CM, Caldera Medical (2013) Summary page 4.

## Indications for use
Vertessa® Lite may be used for the repair of uterine or vaginal vault prolapse that require support material. It may be used in open or laparoscopic abdominal procedures.

Source page: https://510kreport.com/device/K150016
Methodology: https://510kreport.com/methodology