# K092357: Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4 in, 8PLY, Chitogauze, Packaging Strip, 1/2

- Pathway: 510(k) (Special)
- Applicant: Hem Con Medical Technologies, Inc.
- Decided: Aug 25, 2009 after 21 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: 7 generations back to K002550 (2000). 16 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090026: Chitogauze, Models 130, 131, 263, 264, 265, 266, Hem Con Medical Technologies, Inc. (2009) Summary page 5.

## Most influential descendants
- K102546: Chitogauze (2010), 9 descendants of its own
- K142363: Nustat, Nustat XR (2015), 4 descendants of its own
- K222189: SiOxD Wound Matrix (2022), 2 descendants of its own
- K153582: Prometheus ChitoGauze XR PRO (2016), 2 descendants of its own
- K232847: SiOxD Wound Matrix (2023), 1 descendant of its own

## Indications for use
ChitoGauze TM is a hemostatic dressing for the external, temporary control of severely bleeding wounds. ChitoGauze TM is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.

Source page: https://510kreport.com/device/K092357
Methodology: https://510kreport.com/methodology