SGY

Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant

Product code

SGY

Device name

Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant

Device class

Class 2

21 CFR

21 CFR 876.5881

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Life-sustaining / life-supporting

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

A hypothermic machine perfusion system and accessories for orthotopic liver transplant is a device that performs oxygenated perfusion of liver grafts at sub-physiological temperatures until it is transplanted into a recipient patient. This generic type of device may also include perfusion sets, oxygenators, and other components of the perfusion circuit.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-01-15.