K253302

Hemospray Endoscopic Hemostat (HEMO-[X])

510(k) number
K253302
Device name
Hemospray Endoscopic Hemostat (HEMO-[X])
Applicant
Wilson-Cook Medical, Inc. NC · US
Product code
QAU — Hemostatic Device For Endoscopic Gastrointestinal Us
Decision date
2026-06-02
Date received
2025-09-29
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
510(k) Summary (official FDA PDF): K253302.pdf
Official FDA record: K253302
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.