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K Number
K202542
Device Name
Allura Vaginal Stent
Manufacturer
PMT Corporation
Date Cleared
2020-09-30

(28 days)

Product Code
KXP
Regulation Number
884.3900
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Allura™ Vaginal Stent is indicated to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina.

Device Description

Not Found

AI/ML Overview

I am unable to provide a description of the acceptance criteria and the study that proves the device meets them because the provided text is a 510(k) clearance letter for the Allura™ Vaginal Stent and does not contain information about acceptance criteria or supporting studies. It merely states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

§ 884.3900 Vaginal stent.

(a)
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.(b)
Classification. Class II (performance standards).