# Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
> **Product code: SGY** · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5881
## Classification
- **FDA Product Code:** SGY
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 876.5881
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** Y
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SGY)
---
*AI Analytics · CC0 1.0*