# DEN170015: Hemospray Endoscopic Hemostat

- Pathway: De Novo (Direct)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: May 7, 2018 after 424 days
- Product code: QAU (Hemostatic Device For Endoscopic Gastrointestinal Use)
- Device class: 2
- Regulation: 21 CFR 878.4456
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K210098: PuraStat-GI (2021), 4 descendants of its own
- K222481: PuraStat (2023), 3 descendants of its own
- K242250: PuraStat (2024), 2 descendants of its own
- K253924: PuraStat (2026), 1 descendant of its own
- K190677: EndoClot (2021), 1 descendant of its own

## Indications for use
The COOK Hemospray® Endoscopic Hemostat is used for hemostasis of non-variceal gastrointestinal bleeding.

Source page: https://510kreport.com/device/DEN170015
Methodology: https://510kreport.com/methodology