DeviceClearance

Product code SGY— Gastroenterology, Urology

VitaSmart Hypothermic Oxygenated Perfusion System

Classification name
Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
Device class
Class 2
Regulation
21 CFR 876.5881
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SGY under 21 CFR 876.5881, via openFDA

Market context for product code SGY

FDA has cleared 1 device under product code SGY, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SGY

Recent clearances under product code SGY

Data sourced from openFDA. This site is unofficial and independent of the FDA.