# K974479: Silimed Vaginal Stent

- Pathway: 510(k) (Traditional)
- Applicant: Silimed, LLC
- Decided: Aug 5, 1998 after 252 days
- Product code: KXP (Stent, Vaginal)
- Device class: 2
- Regulation: 21 CFR 884.3900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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. Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K974479
Methodology: https://510kreport.com/methodology