# K081275: Boston Scientific Surgical Mesh

- Pathway: 510(k) (Abbreviated)
- Applicant: Boston Scientific Corp
- Decided: Aug 27, 2008 after 114 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K011251 (2001). 8 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073703: Ams Miniarc Sling System, American Medical Systems, Inc. (2008) Summary page 1.
- (no number) Advantage® Transvaginal Mid Urethral Sling System: named in the summary without a submission number
- (no number) Advantage Fit™ System: named in the summary without a submission number
- (no number) Lynx® Suprapubic Mid Urethral Sling System: named in the summary without a submission number
- (no number) Obtryx® Transobturator Mid Urethral Sling System: named in the summary without a submission number
- (no number) Prefyx PPS® System: named in the summary without a submission number

## Most influential descendants
- K083471: GMD Universal Sling, Model Product Code 1010 and 1020 (2009), 3 descendants of its own
- K101440: GMD Universal Urinary Incontinence Sling, Model 1012 (2010), 1 descendant 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
- K103022: KIM (2011), 0 descendants of its own
- K111219: GMD Universal Urinary Incontinence Sling (2011), 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 urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K081275
Methodology: https://510kreport.com/methodology