# K963329: Ethicon Endosuture System

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Oct 25, 1996 after 63 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ENDOLOOP Ligature with Introducer: named in the summary without a submission number
- (no number) Pre-Tied Loop Suture Cannula: named in the summary without a submission number

## Most influential descendants
- K060721: Lariat Loop Applicator (2006), 4 descendants of its own
- K090385: Lariat II Suture Delivery Device (2009), 2 descendants of its own
- K142241: LARIAT sulture Delivery Device (2014), 1 descendant of its own
- K153096: LARIAT RS Suture Delivery Device (2015), 0 descendants of its own
- K102931: G-Cinch Suture Grasper (2010), 0 descendants of its own

## Indications for use
Introduces sutures and facilitates knot tying of surgical sutures in endoscopic (videoscopic) procedures.

Source page: https://510kreport.com/device/K963329
Methodology: https://510kreport.com/methodology