21 CFR § 884.5070 Obstetrical and Gynecological Devices

§ 884.5070 Vacuum abortion system.

Current through Sep 8, 2026 · Read all of Part 884

(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).

← § 884.5050 Metreurynter-balloon abortion system.§ 884.5100 Obstetric anesthesia set. →