FDA Grants Class II Status For Power Morcellator Containment Systems

The agency will require 510(k) clearance for the devices, which can be used to isolate tissue removed from the uterus during morcellation. However, labeling will need to state that the systems have not been proven to reduce the risk of cancer.

Laparoscopic power morcellator containment systems will be regulated as class II devices with special controls, including requirements for 510(k) submissions and device labeling that matches the strong warnings about spreading cancer required for power morcellators themselves. FDA announced the classification policy in a June 20 final order.

The first product in this category, Advanced Surgical Concepts’PneumoLiner, was cleared via the de novo process in April. (See