# K974098: Pubouurethral Sling

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jan 28, 1998 after 90 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.
83 later devices descend from it; 12 cite it directly.
0 of 84 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) ProteGen Sling Collagen Impregnated Material: named in the summary without a submission number

## Most influential descendants
- K020110: Modification to Trelex Mesh Surgical Mesh (2002), 38 descendants of its own
- K041632: Minimesh Polypropylene Mesh (2004), 27 descendants of its own
- K020652: Herniamesh T-Sling (2002), 19 descendants of its own
- K053361: Modification to: Minimesh Polypropylene Mesh (2006), 16 descendants of its own
- K031767: Mentor Obtape Trans-Obturator Tape (2003), 15 descendants of its own

## Indications for use
The TVT device is a sterile, single-use device intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypemmobility and/or intrinsic sphincter deficiency. The TVT Introducer and Rigid Catheter Guide accessories are intended to facilitate placement of the TVT device. The accessories, available separately, are provided non-sterile and are reusable.

Source page: https://510kreport.com/device/K974098
Methodology: https://510kreport.com/methodology