# K222909: Axiostat Gauze

- Pathway: 510(k) (Traditional)
- Applicant: Advamedica, Inc.
- Decided: Apr 7, 2023 after 193 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K002550 (2000). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143462: AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use), Benq Materials Corporation (2015) Summary page 5.

## Indications for use
The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.

Source page: https://510kreport.com/device/K222909
Methodology: https://510kreport.com/methodology