# K110420: Ophira Mini Sling System

- Pathway: 510(k) (Traditional)
- Applicant: Promedon S.A
- Decided: May 8, 2012 after 449 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: 9 generations back to K011251 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100807: Miniarc Precise Single-Incision Sling System Model: 720181, 720191, American Medical Systems, Inc. (2010) Summary page 1.

## Indications for use
OphiraTM Mini Sling System is intended to be used for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinisic sphincter deficiency (ISD).

Source page: https://510kreport.com/device/K110420
Methodology: https://510kreport.com/methodology