Genesys HTA ProCerva

Device typeCirculating-fluid endometrial-ablation catheter: A device in the form of a thin tube with an inflatable balloon at its distal tip intended to be used to provide heat ablation (typically at a temperature of approximately 150°C) of the interior lining of the uterus (endometrium) for the treatment of dysfunctional uterine bleeding (menorrhagia). It is designed to be attached to a hand-held control unit in which a fluid medium (e.g., glycerin) is heated before being forced into the catheter balloon under pressure to compress against the uterine wall and circulate within for homogenous heat distribution. This is a single-use device.

FDA categoryDevice, Thermal Ablation, Endometrial

Device ID00850033976038

Catalog numberM006580210

AvailabilityPrescription

Single useYes

SterileYes

MRI safetyLabeling does not contain MRI Safety Information

Phone855-646-7874

Emailcustomerservice@minervasurgical.com