# K031443: Lsi Solutions Suture Quick Load Products

- Pathway: 510(k) (Abbreviated)
- Applicant: Lsi Solutions
- Decided: Jun 18, 2003 after 43 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930738 (1994). 3 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930738: Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc, Deknatel, Inc. (1994) Summary page 2.
- K984374: Surgisorb, Samyang Corp. (1999) Summary page 2.
- K013274: Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile, Cp Medical (2001) Summary page 2.

## 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
- K203120: RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene (2020), 0 descendants of its own

## Indications for use
The SEW-RIGHPQuick Load" Unit with PTFE coated, braided polyester surgical suture is indicated for use in general soft tissue approximation andor ligation. The SEW-RIC;H$ Quick LoadQUnit with monofilament polypropylene surgical suture is indicated for use in general soft tissue approximation andor ligation. The SEW- RIG^ Quick Load@Unit with STRONGSORBTMsynthetic absorbable surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. The S E W - R E H ~ Quick Load" Unit with MonoglideTMsynthetic absorbable surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Source page: https://510kreport.com/device/K031443
Methodology: https://510kreport.com/methodology