# K111163: Chitogauze Fusion

- Pathway: 510(k) (Special)
- Applicant: Hem Con Medical Technologies, Inc.
- Decided: May 17, 2011 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: 9 generations back to K002550 (2000). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 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.
- 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, Hem Con Medical Technologies, Inc. (2009) Summary page 5.
- K102546: Chitogauze, Hem Con Medical Technologies, Inc. (2010) Summary page 5.

## Indications for use
The ChitoGauze™ FUSION™ Wound Packing Kit is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

Source page: https://510kreport.com/device/K111163
Methodology: https://510kreport.com/methodology