FDA product code SGY: Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant

SGY is the FDA product code for hypothermic machine perfusion system and accessories for orthotopic liver transplant. It is a Class II device, regulated under 21 CFR 876.5881 and reviewed by the Gastroenterology and Urology panel. Devices under SGY reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for SGY devices

openFDA lists no recalls for product code SGY.

Frequently asked questions

What is FDA product code SGY?

SGY is the FDA product code for hypothermic machine perfusion system and accessories for orthotopic liver transplant. It is a Class II device, regulated under 21 CFR 876.5881 and reviewed by the Gastroenterology and Urology panel.

What device class is SGY?

Class II, regulation 21 CFR 876.5881. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SGY
• Run a recall and safety report across every SGY manufacturer
• Watch product code SGY for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times