21 C.F.R. Subpart D—Obstetrical and Gynecological Prosthetic Devices
Title 21 - Food and Drugs
(a) Identification. A cervical drain is a device designed to provide an exit channel for draining discharge from the cervix after pelvic surgery. (b) Classification. Class II (performance standards). (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). (a) Identification. A fallopian tube prosthesis is a device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive surgery. (b) Classification. Class II (performance standards). (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart D—Obstetrical and Gynecological Prosthetic Devices
§ 884.3200 Cervical drain.
§ 884.3575 Vaginal pessary.
§ 884.3650 Fallopian tube prosthesis.
§ 884.3900 Vaginal stent.
