Medical Devices; Obstetrical and Gynecological Devices;   Classification of the Gynecologic Laparoscopic Power Morcellation   Containment System. Final order.
The Food and Drug Administration (FDA) is classifying the gynecologic laparoscopic power morcellation containment system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the gynecologic laparoscopic power morcellation containment system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification; D005260:Female; D006176:Gynecology / Q000145:classification* / Q000295:instrumentation*; D006801:Humans; D020706:Laparoscopes / Q000145:classification*; D000069577:Morcellation / Q000145:classification* / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration