Stent, Vaginal
The Vaginal Stent is a device used to maintain vaginal patency, particularly following vaginal surgery, radiation therapy, or in the management of vaginal stenosis, by mechanically holding the vaginal canal open during the healing or treatment process. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KXP, regulated under 21 CFR 884.3900, in the Obstetrics/Gynecology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- KXP
- Device Class
- FDA class 2
- Regulation Number
- 884.3900
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K202542 | Allura Vaginal Stent | Sep 30, 2020 | Substantially Equivalent | Pmt Corporation |
| K983045 | AMIELLE | Nov 25, 1998 | Substantially Equivalent | Owen Mumford USA, Inc. |
| K974479 | SILIMED VAGINAL STENT | Aug 05, 1998 | Substantially Equivalent | Silimed, LLC |
| K920633 | PESSARY FLEXIBLE SILICONE NICHOLS | Nov 08, 1995 | Substantially Equivalent | Bioteque America, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.