# K012628: Gynecare Tension-Free Vaginal Tape System

- Pathway: 510(k) (Traditional)
- Applicant: Gynecare Center
- Decided: Oct 26, 2001 after 74 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.
18 later devices descend from it; 4 cite it directly.
0 of 19 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 Tension Free Vaginal Tape (TVT) System with Accessories: named in the summary without a submission number
- (no number) TVT Reusable Introducer: named in the summary without a submission number
- (no number) TVT Reusable Rigid Catheter Guide: named in the summary without a submission number
- (no number) Cook OB/GYN Stamey Needle: named in the summary without a submission number

## Most influential descendants
- K050516: T-Sling (2006), 13 descendants of its own
- K072456: Desara Mesh Sling, Model Cal-DS01 (2008), 10 descendants of its own
- K101169: Desara Mesh Model: Cal-DS01 (2010), 5 descendants of its own
- K112609: Desara Mesh (2011), 3 descendants of its own
- K083471: GMD Universal Sling, Model Product Code 1010 and 1020 (2009), 3 descendants of its own

## Indications for use
The TVT device is intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI) for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The TVT Introducer, Rigid Catheter Guide and TVT Abdominal Guides and Couplers are accessories intended to facilitate placement of the TVT device.

Source page: https://510kreport.com/device/K012628
Methodology: https://510kreport.com/methodology