# K121641: Miniarc Pro Single-Incision Sling System

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems
- Decided: Sep 7, 2012 after 95 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K011251 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100807: Miniarc Precise Single-Incision Sling System Model: 720181, 720191, American Medical Systems, Inc. (2010) Summary page 1.

## Recalls of this device
- Oct 26, 2015 · Class II · Z-0279-2016: The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical 

## Indications for use
The MiniArc®8 Pro Single-Incision Sling System is intended for the placement of a sub-urethral sling for the treatment of female stress urinary incontinence (SUL) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Source page: https://510kreport.com/device/K121641
Methodology: https://510kreport.com/methodology