KXP · Stent, Vaginal
Obstetrics/Gynecology · 21 CFR 884.3900 · Class 2
Overview
| Product Code | KXP |
|---|---|
| Device Name | Stent, 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K202542 | Allura Vaginal Stent | Pmt Corporation | Sep 30, 2020 | SESE |
| K983045 | AMIELLE | Owen Mumford USA, Inc. | Nov 25, 1998 | SESE |
| K974479 | SILIMED VAGINAL STENT | Silimed, LLC | Aug 5, 1998 | SESE |
| K920633 | PESSARY FLEXIBLE SILICONE NICHOLS | Bioteque America, Inc. | Nov 8, 1995 | SESE |
Top Applicants
- Bioteque America, Inc. — 1 clearance
- Owen Mumford USA, Inc. — 1 clearance
- Pmt Corporation — 1 clearance
- Silimed, LLC — 1 clearance
