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K Number
K974479
Device Name
SILIMED VAGINAL STENT
Manufacturer
SILIMED, LLC.
Date Cleared
1998-08-05

(252 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 Silimed Vaginal Stent is designed to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina.

The surgeon is responsible for proper choice of size to meet the clinical and aesthetic needs of each case.

Device Description

Silimed Vaginal Stent

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Silimed Vaginal Stent) and its indications for use. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. Therefore, I cannot fulfill your request based on the given input.

§ 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).