# K030123: Bioarc SP Sling Kit

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems, Inc.
- Decided: Feb 6, 2003 after 23 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: 4 generations back to K011251 (2001). 4 ancestors in all.
81 later devices descend from it; 4 cite it directly.
0 of 86 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)
- K013355: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.
- K020663: Modification to Sparc Sling System, American Medical Systems, Inc. (2002) Summary page 1.
- K021263: Modification to Sparc Sling System, American Medical Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K040623: Ams Perigee System (2004), 70 descendants of its own
- K040537: Ams Apogee Vault Suspension System (2004), 70 descendants of its own
- K040538: Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996 (2004), 39 descendants of its own
- K041948: Sparc, Monarc, Bioarc SP and Bioarc to Sling Systems (2004), 37 descendants of its own
- K050445: Ams Collagen Dermal Matrix (2005), 30 descendants of its own

## Indications for use
The BioArc™ SP Sling Kit 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/K030123
Methodology: https://510kreport.com/methodology