RITA gets 510(k)

AuntMinnie.com staff writers
Aug 18, 2005

Oncology device developer RITA Medical Systems has received Food and Drug Administration 510(k) marketing approval for its Habib4X resection device.

The product coagulates a surgical resection plane to facilitate a fast dissection with limited blood loss. The firm believes the product will be utilized in liver cancer surgeries, as it is designed to minimize blood loss and blood transfusion. Additionally the device is designed to work on the current RITA radiofrequency ablation platform of 1500X generators, the company said.

Habib4X is also labeled with the CE Mark for distribution in Europe, RITA said. The developer expects to begin shipping the product in mid-September, according to the Fremont, CA-based firm.

By AuntMinnie.com staff writers
August 19, 2005

Related Reading

Martinez joins RITA, August 18, 2005

RITA launches safety needle, August 16, 2005

RITA debuts new ports, July 28, 2005

RITA brings new auditor on board, July 5, 2005

RITA transfers manufacturing to Georgia, June 23, 2005

Copyright © 2005 AuntMinnie.com

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