# K042949: Pelvilace Transobturator Biourethral Support System (Pelvilace to System)

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 9, 2004 after 14 days
- Product code: PAG (Mesh, Surgical, Non-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.
No later device cites it as a predicate yet.
0 of 1 device 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) InnerLace™ BioUrethral Support System: named in the summary without a submission number
- (no number) Uretex™ TO Transobturator Urethral Support System: named in the summary without a submission number

## Indications for use
The PelviLace™ Transobturator BioUrethral Support System is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgicat repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use as a pubourethral sling for the treatment of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K042949
Methodology: https://510kreport.com/methodology