# K981531: Suture Placement Device and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Lsi Solutions
- Decided: Jul 13, 1998 after 75 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K954853 (1995). 1 ancestor in all.
16 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954853: Auto Suture Suture Closure, United States Surgical, A Division of Tyco Healthc (1995) Summary page 1.

## Most influential descendants
- K123811: Stitchkit (2013), 6 descendants of its own
- K040232: Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999 (2004), 6 descendants of its own
- K100593: Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series Suture Placeme (2010), 5 descendants of its own
- K173874: StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO (2018), 3 descendants of its own
- K202950: StitchKit COMBO (2021), 2 descendants of its own

## Indications for use
The LSI Suture Placement device and accessories are intended for use in the approximation of soft tissue.

Source page: https://510kreport.com/device/K981531
Methodology: https://510kreport.com/methodology