Saniserv, Inc.
Country not established
- Devices
- 1
What Saniserv, Inc. makes
Saniserv, Inc. manufactures the Saniserv Surgical Slush System, a device designed for intraoperative cooling and temperature management in surgical procedures. This system is intended to maintain tissue temperatures during operations where heat dissipation is critical, such as in orthopedic or spinal surgeries.
The company’s portfolio is regulated under Class I medical devices in the United States, with the Saniserv Surgical Slush System listed via the FDA’s 510(k) pathway. The device is included in regulatory registries under the FDA’s clearance requirements for non-significant risk surgical equipment.
Catalogue
Saniserv Surgical Slush System Ref K894006
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Saniserv, Inc. have in the registry?
The registry currently lists 1 device for Saniserv, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Saniserv, Inc.'s devices?
Among its 1 most recently registered device, Saniserv, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Saniserv, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Saniserv, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Saniserv, Inc. in the registry?
The most recently registered devices listed for Saniserv, Inc. include SANISERV SURGICAL SLUSH SYSTEM.