Servator P SALF Solution with THAM
by S.A.L.F. Spa EUDAMED510(k)
Active
510(k) K202652
Overview
The Servator P SALF Solution with THAM is a System, Perfusion, Kidney, designed for use in renal perfusion procedures. This solution contains tris(hydroxymethyl)aminomethane (THAM) and is intended to maintain cellular integrity and metabolic function during kidney preservation and transport.
Supplied as a sterile, single-use solution, this device is regulated under FDA 510(k) clearance and EU MDR compliance. It is intended for use in controlled medical settings, such as operating rooms or perfusion laboratories, and must be stored under appropriate conditions to preserve sterility. The solution is classified as a Class II medical device under FDA regulations.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK202652 | Date19 Aug 2021 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KDN
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5880
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from S.A.L.F. Spa
Questions
What is the primary purpose of the Servator P SALF Solution with THAM in clinical settings?
The Servator P SALF Solution with THAM is specifically designed for renal perfusion procedures, where it helps maintain cellular integrity and metabolic function during kidney preservation and transport. This ensures the kidney remains viable and functional during storage and transfer to the operating room or transplant site.
Is the Servator P SALF Solution with THAM intended for single-use or can it be reused?
The Servator P SALF Solution with THAM is supplied as a sterile, single-use solution. Reuse is not recommended or supported, as this could compromise sterility and the solution’s effectiveness in preserving kidney viability.
How should the Servator P SALF Solution with THAM be stored to maintain its sterility and integrity?
The solution must be stored under appropriate conditions to preserve sterility, as specified by the manufacturer. While exact storage instructions are not detailed here, it is generally recommended to follow the manufacturer’s guidelines for temperature, humidity, and protection from contamination to ensure the solution remains effective for its intended use.
What regulatory pathways has the Servator P SALF Solution with THAM undergone, and where is it authorized for use?
The Servator P SALF Solution with THAM has undergone FDA 510(k) clearance and is compliant with EU MDR regulations. This means it is authorized for use in the United States and the European Economic Area, adhering to the respective regulatory standards for medical devices.
What medical specialties are most likely to use the Servator P SALF Solution with THAM?
The Servator P SALF Solution with THAM is primarily associated with the specialties of gastroenterology and urology, as indicated by its regulatory filings. However, its intended use in renal perfusion procedures makes it most relevant for transplant surgeons and renal perfusion specialists working in operating rooms or perfusion laboratories.