# K063136: Needleless Sling

- Pathway: 510(k) (Traditional)
- Applicant: Specialities Remeex International, S.L.
- Decided: Dec 19, 2006 after 64 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: 1 generation back to K052401 (2005). 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)
- K052401: Gynecare TVT Secur System, ETHICON, Inc. (2005) Summary page 1.
- (no number) Gynecare Tension-Free Vaginal Tape System: named in the summary without a submission number

## Indications for use
The NEEDLELESS SLING is indicated for the treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency

Source page: https://510kreport.com/device/K063136
Methodology: https://510kreport.com/methodology