# K200972: Hemospray Endoscopic Hemostat

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jun 10, 2020 after 58 days
- Product code: QAU (Hemostatic Device For Endoscopic Gastrointestinal Use)
- Device class: 2
- Regulation: 21 CFR 878.4456
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170015 (2018). 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)
- DEN170015: Hemospray Endoscopic Hemostat, Wilson-Cook Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- K253302: Hemospray Endoscopic Hemostat (HEMO-[X]) (2026), 0 descendants of its own

## Recalls of this device
- Aug 29, 2024 · Class II · Z-0036-2025: Specific lots of product have been manufactured with nonconforming raw materials.
- May 22, 2023 · Class II · Z-1978-2023: There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuve
- May 22, 2023 · Class II · Z-1979-2023: There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuve

## Indications for use
The COOK Hemospray device is intended for hemostasis of non-variceal bleeds in the GI (gastrointestinal) tract. It is for prescription use only.

Source page: https://510kreport.com/device/K200972
Methodology: https://510kreport.com/methodology