# K011251: Sparc Sling System

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Aug 1, 2001 after 99 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
No predicates in its family tree.
123 later devices descend from it; 13 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013355: Sparc Sling System (2001), 120 descendants of its own
- 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

Source page: https://510kreport.com/device/K011251
Methodology: https://510kreport.com/methodology