21 CFR § 884.3575
Vaginal pessary
June 25, 2020
(a) Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.
(b) Classification. Class II (performance standards).