# K121754: Blue Sui Sling

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Oct 10, 2012 after 118 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: 3 generations back to K945377 (1994). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020110: Modification to Trelex Mesh Surgical Mesh, Boston Scientific (2002) Summary page 1.
- K040787: Modification to Surgical Mesh Polymeric, Boston Scientific (2004) Summary page 1.

## Most influential descendants
- K211223: Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (2021), 1 descendant of its own
- K231549: Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System (2023), 0 descendants of its own
- K172565: Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device (2017), 0 descendants of its own

## Indications for use
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K121754
Methodology: https://510kreport.com/methodology