510(k) · Cleared
ClearedSilimed Vaginal Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silimed, LLC · KXP Stent, Vaginal
Cleared on Aug 5, 1998 after a 252-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 5, 1998
- Review
- 252 days
- Class
- Class II
- Product code
- KXP
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KXP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KXP devicesKXP Stent, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KXP
Too few KXP 510(k)s in any year since 2007 to give a median.
Recalls per year · KXP
No recall names KXP since 2007.
Adverse event reports per year · KXP
1in 2008
MAUDE reports naming product code KXP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974479 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974479: Silimed Vaginal Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974479
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026