# K063713: Ams Smart Sling System

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Feb 22, 2007 after 70 days
- Product code: OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator)
- 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 K011251 (2001). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050516: T-Sling, Herniamesh S.R.L. (2006) Summary page 1.
- K023516: Monarc Sling System, American Medical Systems, Inc. (2002) Summary page 1.
- K011251: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K070846: Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System (2007), 0 descendants of its own

## Indications for use
The Smart Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUT) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K063713
Methodology: https://510kreport.com/methodology