# K083722: Ascend

- Pathway: 510(k) (Traditional)
- Applicant: Caldera Medical, Inc.
- Decided: Mar 31, 2009 after 106 days
- Product code: OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed)
- Device class: 3
- Regulation: 21 CFR 884.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931386 (1993). 23 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040537: Ams Apogee Vault Suspension System, American Medical Systems, Inc. (2004) Summary page 1.
- K040623: Ams Perigee System, American Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K101462: Ascend Blue AC Mesh; Ascend Blue PC Mesh (2010), 6 descendants of its own
- K120327: Vertessa (2012), 5 descendants of its own
- K123337: Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CM (2013), 1 descendant of its own
- K122440: Restorelle L (2012), 1 descendant of its own
- K150016: Vertessa Lite (2015), 0 descendants of its own

## Indications for use
Ascend AC and Ascend PC are indicated for repair of pelvic organ prolapse, including anterior, posterior, vaginal vault and uterine prolapse.

Source page: https://510kreport.com/device/K083722
Methodology: https://510kreport.com/methodology