FDAnews Device Daily Bulletin

FDA Classifies Power Morcellation Containment Systems as Class II Devices

June 29, 2016

FDA is classifying gynecologic laparoscopic power morcellation containment systems as Class II, special control devices.

Devicemakers submitting a premarket notification for these morcellation containment systems will need to comply with the special controls named in the final order issued on June 21.

On April 8, the FDA approved Advanced Surgical Concepts’ PneumoLiner, the first containment system for use in conjunction with laparoscopic power morcellators intended to isolate uterine tissue that is not suspected to contain cancer.

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