# K090385: Lariat II Suture Delivery Device

- Pathway: 510(k) (Traditional)
- Applicant: Sentreheart, Inc.
- Decided: May 6, 2009 after 78 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: 3 generations back to K931994 (1994). 8 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K060721: Lariat Loop Applicator, Sentreheart (2006) Summary page 2.
- K963329: Ethicon Endosuture System, ETHICON, Inc. (1996) Summary page 2.
- K022410: Saph-Loop Ligating Loop, Genzyme Biosurgery (2002) Summary page 2.
- K905379: Auto Suture Modified Surgitie Endo. Ligating Loop, United States Surgical, A Division of Tyco Healthc (1991) Summary page 2.

## Most influential descendants
- K142241: LARIAT sulture Delivery Device (2014), 1 descendant of its own
- K153096: LARIAT RS Suture Delivery Device (2015), 0 descendants of its own

## Indications for use
The LARIAT II Suture Delivery Device facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.

Source page: https://510kreport.com/device/K090385
Methodology: https://510kreport.com/methodology