# K093904: Glenveigh Vaginal Tamponade Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Glenveigh Surgical, LLC
- Decided: Apr 14, 2010 after 113 days
- Product code: KNA (Instrument, Manual, Specialized Obstetric-Gynecologic)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972077 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060289: Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01, Frontline Medical (2006) Summary page 1.

## Indications for use
The Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal laceration repair to temporarily prevent the post partumn discharge of fluids from the vagina in order to assist with the episiotomy/laceration repair procedure.

Source page: https://510kreport.com/device/K093904
Methodology: https://510kreport.com/methodology