Home » Attune Medical Receives 510(k) Clearance for New EnsoETM Models
Attune Medical Receives 510(k) Clearance for New EnsoETM Models
Devices Submissions and Approvals
Attune Medical received 510(k) clearance for new models of its EnsoETM temperature management device to raise or maintain patient temperature with Cincinnati Sub-Zero’s Norm-O-Temp hyperthermia system.
The device manages patient temperature through the esophagus. The clearance includes EnsoETM with ENFit, which allows for enteral fluid administration through the device, and the original EnsoETM.
Two lumens attach to an external heat exchange unit while a third, independent, lumen simultaneously allows gastric decompression and drainage, as well as the administration of enteral fluids such as tube feeds and medications in some models.