# K040789: Durabraid Suture

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 4, 2004 after 67 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Surgical Specialties Corporation Polyviolene green and white braided polyester surgical suture line: named in the summary without a submission number

## Most influential descendants
- K063194: Tufflex Polyester Suture (2006), 0 descendants of its own

## Indications for use
Smith & Nephew DurabraidTM Suture is indicated for use in approximation and/or ligation of soft tissues.

Source page: https://510kreport.com/device/K040789
Methodology: https://510kreport.com/methodology