# K062341: Male Remeex System

- Pathway: 510(k) (Traditional)
- Applicant: Specialities Remeex International, S.L.
- Decided: Nov 2, 2006 after 84 days
- Product code: OTM (Mesh, Surgical, For Stress Urinary Incontinence, Male)
- 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: 1 generation back to K033310 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033310: Remeex System for Urinary Incontinence, Specialities Remeex International, S.L. (2004) Summary page 1.

## Indications for use
The Male Remeex System is intended to be used as a pubourethral sling for the treatment of male stress urinary incontinence

Source page: https://510kreport.com/device/K062341
Methodology: https://510kreport.com/methodology