# K061796: Hepatostat Set, Model 760X

- Pathway: 510(k) (Traditional)
- Applicant: Vygon Corp.
- Decided: Nov 2, 2006 after 129 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: 2 generations back to K944110 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924223: Mar-Med Liver Strap, Mar-Med Co. (1993) Summary page 1.
- K031286: Safil and Safil Quick Synthetic Absorbable Surgical Suture, Aesculap, Inc. (2003) Summary page 1.
- K011375: Aesculap, Inc., Monosyn Synthetic Absorbable Surgical Suture, Aesculap, Inc. (2001) Summary page 1.
- K033746: Modified Coated Vicryl* Rapide (Polyglactin 910) Suture, ETHICON, Inc. (2003) Summary page 1.

## Most influential descendants
- K073493: Hepatostat Set (2008), 0 descendants of its own

## Indications for use
Hepatostat Set is a compression system acting as a tourniquet on the hepatic tissue. It is intended to reduce the risk of bleeding and to achieve hemostasis in hepatic resections (from large to small superficial hepatectomy). It can also be used for traumatic liver injuries.

Source page: https://510kreport.com/device/K061796
Methodology: https://510kreport.com/methodology