510(k) K253302 ยท QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Hemospray Endoscopic Hemostat (HEMO-[X])
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Jun 2, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253302
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Wilson-Cook Medical Inc. Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT
Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT
Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU
Software Version: N/A
Product Description: Hemostatic Open, Classified |
QAU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.