# K253302: Hemospray Endoscopic Hemostat (HEMO-[X])

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jun 2, 2026 after 246 days
- Product code: QAU (Hemostatic Device For Endoscopic Gastrointestinal Use)
- Device class: 2
- Regulation: 21 CFR 878.4456
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170015 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200972: Hemospray Endoscopic Hemostat, Wilson-Cook Medical, Inc. (2020) Summary page 5.

## Recalls of this device
- Aug 20, 2026 · Class II · Z-3177-2026: Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

## Indications for use
The Hemospray® Endoscopic Hemostat is used in adult patients for the hemostasis of nonvariceal gastrointestinal bleeding due to endoscopic procedures and medical conditions such as inflammatory lesions, GI vascular abnormalities, tumors, and ulcers.

Source page: https://510kreport.com/device/K253302
Methodology: https://510kreport.com/methodology