21 CFR § 884.1175
Endometrial suction curette and accessories
June 25, 2020
(a) Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.
(b) Classification. Class II (performance standards).