# K102965: Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma Gauze AG, Omni-Stat Hemostatic Anti

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products, Ltd.
- Decided: Dec 8, 2010 after 64 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: 8 generations back to K002550 (2000). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100693: Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial Dressing, Medtrade Products Limited (2010) Summary page 5.
- K091795: Medtrade Products Celox Trauma Gauze, Medtrade Products, Ltd. (2009) Summary page 5.

## Indications for use
CELOX Antibacterial Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding. CELOX Antibacterial Trauma Gauze may be used for the management of partial and full thickness wounds 1st and 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology and pressure ulcers/sores (partial and full thickness), surgical wounds and donor sites.

Source page: https://510kreport.com/device/K102965
Methodology: https://510kreport.com/methodology