# K123337: Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CM

- Pathway: 510(k) (Traditional)
- Applicant: Caldera Medical
- Decided: Feb 21, 2013 after 113 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: 12 generations back to K931386 (1993). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120327: Vertessa, Caldera Medical, Inc. (2012) Summary page 1.

## Most influential descendants
- K150016: Vertessa Lite (2015), 0 descendants of its own

## Indications for use
VertessaTM 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/K123337
Methodology: https://510kreport.com/methodology