# K010931: Ams Sacral Colpopexy Sling, Model 72403501

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems, Inc.
- Decided: Apr 9, 2001 after 12 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: 5 generations back to K931386 (1993). 9 ancestors in all.
80 later devices descend from it; 3 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002721: Ams Triangle Silicone-Coated Sling and Surgical Mesh, American Medical Systems, Inc. (2000) Summary page 4.

## Most influential descendants
- K033636: Ams Large Pore Polypropylene Mesh (2003), 79 descendants of its own
- K040521: Modification to Ams Large Pore Polypropylene Mesh (2004), 74 descendants of its own
- K040623: Ams Perigee System (2004), 70 descendants of its own
- K040537: Ams Apogee Vault Suspension System (2004), 70 descendants of its own
- K050445: Ams Collagen Dermal Matrix (2005), 30 descendants of its own

## Indications for use
The AMS Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISOD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.

Source page: https://510kreport.com/device/K010931
Methodology: https://510kreport.com/methodology