HFK · Mold, Vaginal
Obstetrics/Gynecology · 21 CFR 884.3900 · Class 2
Overview
| Product Code | HFK |
|---|---|
| Device Name | Mold, Vaginal |
| Regulation | 21 CFR 884.3900 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K920838 | MEDSURG CIRCUMCISION TRAY | Medsurg Industries, Inc. | Oct 15, 1993 | SESE |
Top Applicants
- Medsurg Industries, Inc. — 1 clearance
