# K060289: Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01

- Pathway: 510(k) (Traditional)
- Applicant: Frontline Medical
- Decided: Jul 7, 2006 after 151 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: 1 generation back to K972077 (1997). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013597: Tamponade Uterine Balloon Catheter Set, Cook Ob/Gyn (2002) Summary page 1.
- K972077: Epi-Stop Epistaxis Catheter, Boston Medical Products, Inc. (1997) Summary page 1.
- (no number) National Hospital Packaging Vag Packing: named in the summary without a submission number

## Most influential descendants
- K091958: Belfort-Dildy Obstetric Tamponade System (2010), 2 descendants of its own
- K150573: ebb Complete Tamponade System (2015), 1 descendant of its own
- K153591: ebb Complete Tamponade System (2016), 0 descendants of its own
- K093904: Glenveigh Vaginal Tamponade Balloon Catheter (2010), 0 descendants of its own

## Indications for use
EpiStat is intended for use by physicians and trained obstetrics/gynecology nurse practitioners during episiotomy repair procedures. EpiStat is intended to temporarily tamponade the post partum discharge from the vagina in order to assist with the episiotomy repair procedure. V-Stat is intended for use by physicians for temporary haemostatic control following vaginal surgery procedures such as (a) post operative packing for posterior and anterior vaginal repairs (b) brisk introperative bleeding during urethral sling procedures and post operative packing to control sub-pubic haematoma following urethral sling procedures.

Source page: https://510kreport.com/device/K060289
Methodology: https://510kreport.com/methodology