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, a class II device type, regulated under 21 CFR 876.5881. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SGY
- Device name
- Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
- FDA 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.
- Regulation
- 21 CFR 876.5881
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SGY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2026 | 1 |
Applicants with the most clearances
Product code SGY| Applicant | Clearances |
|---|---|
| Bridge to Life Ltd | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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