# K042031: Opus Speedstitch Suture Device

- Pathway: 510(k) (Traditional)
- Applicant: Opus Medical, Inc.
- Decided: Oct 19, 2004 after 83 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
0 of 15 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) Opus SmartStitch® Suture Device: named in the summary without a submission number

## Most influential descendants
- K061386: Anchor Band Suturing System, Model SR-AB (2006), 11 descendants of its own
- K062307: Xclose Tissue Repair System, Model SRS (2006), 9 descendants of its own
- K100572: Versaclose, Model VC-200-01 (2010), 7 descendants of its own
- K091432: Xclose Tissue Repair System, Model XC-200-01 (2009), 7 descendants of its own
- K111462: Fixate Tissue Band (2011), 6 descendants of its own

## Recalls of this device
- Aug 8, 2011 · Not classified · Z-0611-2012: Product is being removed from the field due to an over-label issue.

## Indications for use
Is indicated for use for in placement of suture through soft tissue in endoscopic and other limited access procedures.

Source page: https://510kreport.com/device/K042031
Methodology: https://510kreport.com/methodology