# K993695: Liga-Loop Suture Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Hysterx, Inc.
- Decided: Apr 13, 2000 after 163 days
- Product code: GAL (Suture, Absorbable, Natural)
- Device class: 2
- Regulation: 21 CFR 878.4830
- 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 K931994 (1994). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950126: Endoscopic Ligation Device, Ligator Handle, Ligator Cartridge, Advanced Surgical, Inc. (1995) Summary page 1.
- K931994: Resectoscope Sheath, Olympus Corp. (1994) Summary page 1.

## 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
- K073096: Anchorage Closure Device (2008), 0 descendants of its own

## Indications for use
The LIGA-LOOP Suture Applicator is intended for use in the suturing of soft tissue and ligation of blood vessels during open and guidance-assisted surgical procedures. The LIGA-LOOP Suture Applicator with polyglycolic acid (PGA) suture and the LIGA-LOOP Suture Applicator with gut suture (plain and chromic) are intended for the same use, excluding cardiovascular and neurological procedures.

Source page: https://510kreport.com/device/K993695
Methodology: https://510kreport.com/methodology