21 CFR 884.3575 — Pessary, Vaginal
Obstetrics/Gynecology (OB) · Part 884 Subpart D—Obstetrical and Gynecological Prosthetic Devices · § 884.3575
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HHW | Pessary, Vaginal | 2 | 41 | 3rd Party |
