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Power Morcellation Containment Devices Placed In FDA Class II

 
• By Elizabeth Orr

The special controls are to include biocompatibility, sterility and performance testing, as well as physician training and warning labels.

Olympus Bag Morcellator
Contained tissue extraction system from Olympus America. • Source: Olympus America

Medical devices that help reduce the risk that malignant cells may spread elsewhere in the body during power morcellation procedures will be regulated as moderate-risk class II, the US Food and Drug Administration announced on 22 November. The device type is known as general laparoscopic power morcellation containment systems.

The classification was requested by Advanced Surgical Concepts whose ContainOR was the first device in the category to receive...

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