# K040232: Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999

- Pathway: 510(k) (Special)
- Applicant: Lsi Solutions
- Decided: Mar 1, 2004 after 28 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
Longest line of descent: 2 generations back to K954853 (1995). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981531: Suture Placement Device and Accessories, Lsi Solutions (1998) Summary page 1.

## Most influential descendants
- K100593: Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series Suture Placeme (2010), 5 descendants of its own
- K160529: Pledgeted COR-SUTURE QUICK LOAD (2016), 1 descendant of its own
- K141206: Edwards Lifesciences Thruport Knotting System (2015), 1 descendant of its own
- K222783: MD Mattress Suture Placement Device (2024), 0 descendants of its own
- K203081: RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture (2020), 0 descendants of its own

## Indications for use
Approximation of soft tissue

Source page: https://510kreport.com/device/K040232
Methodology: https://510kreport.com/methodology