# K022410: Saph-Loop Ligating Loop

- Pathway: 510(k) (Special)
- Applicant: Genzyme Biosurgery
- Decided: Aug 20, 2002 after 27 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 K001440 (2000). 1 ancestor in all.
5 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)
- K001440: Nextstitch Cardiovascular Valve Suture, Genzyme Surgical Product (Genzyme Biosurgery) (2000)

## 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 Saph-Loopm Ligating Loop is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K022410
Methodology: https://510kreport.com/methodology