# K070065: Ams Single Incision Sling System (Sis-0)

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems, Inc.
- Decided: Mar 1, 2007 after 52 days
- Product code: PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling)
- 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). 5 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023516: Monarc Sling System, American Medical Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K071902: Ams Miniarc Sling System (2007), 16 descendants of its own
- K073703: Ams Miniarc Sling System (2008), 15 descendants of its own
- K081275: Boston Scientific Surgical Mesh (2008), 5 descendants of its own
- K083471: GMD Universal Sling, Model Product Code 1010 and 1020 (2009), 3 descendants of its own
- K121562: Altis Single Incision Cling System (2012), 2 descendants of its own

## Indications for use
The Single Incision Sling System is intended for the placement of a suburethral 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/K070065
Methodology: https://510kreport.com/methodology