# K073493: Hepatostat Set

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: May 6, 2008 after 146 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- 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 K944110 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061796: Hepatostat Set, Model 760X, Vygon Corp. (2006) Summary page 1.

## Indications for use
Hepatostat Set is an absorbable compression system acting as a tourniquet on the hepatic, splenic and nephric tissue. It is used to achieve hemostasis in hepatic, splenic, and nephric resections. It can also be used for traumatic liver, kidney and spleen injuries. It is designed to provide compressive hemostasis to the wound site, and resorb naturally over time after hemostasis has been achieved.

Source page: https://510kreport.com/device/K073493
Methodology: https://510kreport.com/methodology