# K100593: Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series Suture Placeme

- Pathway: 510(k) (Traditional)
- Applicant: Lsi Solutions, Inc.
- Decided: Oct 13, 2010 after 225 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
Longest line of descent: 4 generations back to K933887 (1993). 14 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 20 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.
- K011016: Lsi Solutions Flexible Suture Placement Device and Accessories Product, Lsi Solutions (2001)
- K040232: Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999, Lsi Solutions (2004) Summary page 1.
- K031443: Lsi Solutions Suture Quick Load Products, Lsi Solutions (2003) Summary page 1.
- K012317: Coalescent Surgical U-Clip, Coalescent Surgical (2001)

## Most influential descendants
- 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
- K150882: Edwards Suture Fastening System (2015), 0 descendants of its own

## Indications for use
Approximation of soft tissue and prosthetic materials

Source page: https://510kreport.com/device/K100593
Methodology: https://510kreport.com/methodology