# K100807: Miniarc Precise Single-Incision Sling System Model: 720181, 720191

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Jun 7, 2010 after 77 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: 8 generations back to K011251 (2001). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070065: Ams Single Incision Sling System (Sis-0), American Medical Systems, Inc. (2007) Summary page 2.
- K071902: Ams Miniarc Sling System, American Medical Systems, Inc. (2007) Summary page 2.
- K073703: Ams Miniarc Sling System, American Medical Systems, Inc. (2008) Summary page 2.

## Most influential descendants
- K121641: Miniarc Pro Single-Incision Sling System (2012), 0 descendants of its own
- K110420: Ophira Mini Sling System (2012), 0 descendants of its own

## Indications for use
The MiniArc Precise Single-Incision Sling System is intended for the placement of a sub-urethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Source page: https://510kreport.com/device/K100807
Methodology: https://510kreport.com/methodology