21 CFR 884.3900 — Dilator, Vaginal
Obstetrics/Gynecology (OB) · Part 884 Subpart D—Obstetrical and Gynecological Prosthetic Devices · § 884.3900
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HDX | Dilator, Vaginal | 2 | 9 | 3rd Party |
| HFK | Mold, Vaginal | 2 | 1 | 3rd Party |
| KXP | Stent, Vaginal | 2 | 4 | 3rd Party |
