# K140573: Woundclot Hemostatic Gauze

- Pathway: 510(k) (Traditional)
- Applicant: Core Scientific, Ltd.
- Decided: Nov 24, 2014 after 263 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: 1 generation back to K080532 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080532: Benacel, Models C-001, C-002 and C-005, Unicare Biomedical, Inc. (2008) Summary page 5.

## Most influential descendants
- K160679: WoundClot9 (2016), 0 descendants of its own

## Indications for use
WoundClot Hemostatic Gauze is intended to be used as a topical dressing for local management of bleeding wounds, such as cuts, lacerations and abrasions, and for use as a temporary treatment of severely bleeding wounds, such as surgical wounds (operative, postoperative, donor sites, dermatological) and traumatic injuries.

Source page: https://510kreport.com/device/K140573
Methodology: https://510kreport.com/methodology