# K021834: Suture Fixation Device; Mesh Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Mle, Inc.
- Decided: Aug 28, 2002 after 85 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- 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) Suture retention device: named in the summary without a submission number
- (no number) Soft tissue Fastener: named in the summary without a submission number

## Indications for use
For use in procedures requiring fixation of suspending sutures and/or surgical mesh to soft tissue. This includes but is not limited to pubourethral support and bladder neck support procedures for the treatment of female stress urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

Source page: https://510kreport.com/device/K021834
Methodology: https://510kreport.com/methodology