# K954853: Auto Suture Suture Closure

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Dec 20, 1995 after 58 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
No predicates in its family tree.
19 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K981531: Suture Placement Device and Accessories (1998), 16 descendants of its own
- 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

Source page: https://510kreport.com/device/K954853
Methodology: https://510kreport.com/methodology