# K052401: Gynecare TVT Secur System

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Nov 28, 2005 after 88 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
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) GYNECARE TVT System: named in the summary without a submission number
- (no number) GYNECARE TVT Obturator System: 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
- K070846: Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System (2007), 0 descendants of its own
- K063136: Needleless Sling (2006), 0 descendants of its own

## Indications for use
The GYNECARE TVT SECUR* device is intended for use in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K052401
Methodology: https://510kreport.com/methodology