# K033310: Remeex System for Urinary Incontinence

- Pathway: 510(k) (Traditional)
- Applicant: Specialities Remeex International, S.L.
- Decided: Jan 15, 2004 after 93 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ethicon/Gynecare Pubourethral Sling: named in the summary without a submission number

## Most influential descendants
- K091180: Minitape Urethral Sling (2009), 1 descendant of its own
- K092203: Omnisure Urethral Sling, Model OTK52 (2009), 0 descendants of its own
- K071754: Neo-Vagina Surgery Set and Accessories (2009), 0 descendants of its own
- K062341: Male Remeex System (2006), 0 descendants of its own

## Indications for use
The Remeex System is intended to be used as a pubourethral sling for treatment of female stress urinary incontinence (SUI) resulting from urethral hypomobility or hypermobility and / or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K033310
Methodology: https://510kreport.com/methodology