# K013355: Sparc Sling System

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems, Inc.
- Decided: Oct 26, 2001 after 16 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: 1 generation back to K011251 (2001). 1 ancestor in all.
120 later devices descend from it; 10 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011251: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K020663: Modification to Sparc Sling System (2002), 110 descendants of its own
- K021263: Modification to Sparc Sling System (2002), 109 descendants of its own
- K023516: Monarc Sling System (2002), 102 descendants of its own
- K030123: Bioarc SP Sling Kit (2003), 81 descendants of its own
- K040623: Ams Perigee System (2004), 70 descendants of its own

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

Source page: https://510kreport.com/device/K013355
Methodology: https://510kreport.com/methodology