# K013990: Lifestitch Suturing Device

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Feb 27, 2002 after 86 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: 1 generation back to K972911 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972911: Auto Suture*Endostitch* II** Suture Applier, United States Surgical, A Division of Tyco Healthc (1998) Summary page 1.
- K011016: Lsi Solutions Flexible Suture Placement Device and Accessories Product, Lsi Solutions (2001) Summary page 1.
- K990952: Novafil** and Vascufil** Sterile Synthetic Non-Absorbable Sutures, United States Surgical, A Division of Tyco Healthc (1999) Summary page 1.

## Indications for use
The Edwards Lifesciences LifeStitch Suturing Device is used for the approximation of soft tissue.

Source page: https://510kreport.com/device/K013990
Methodology: https://510kreport.com/methodology