21 CFR § 884.5070
Vacuum abortion system
June 25, 2020
(a) Identification. A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.
(b) Classification. Class II (performance standards).