FDA Product Code SGY: Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
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.
Leading manufacturers include Bridge TO Life, Ltd..
FDA 510(k) Cleared Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant Devices (Product Code SGY)
About Product Code SGY - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SGY since 2026, with 0 receiving FDA clearance (average review time: 290 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SGY devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →