Hemospray Endoscopic Hemostat— 510(k) DEN170015

Unknown

Wilson-Cook Medical, Inc.

FDA 510(k) clearance DEN170015 for Hemospray Endoscopic Hemostat, Unknown on 2018-05-07. Applicant: Wilson-Cook Medical, Inc..

Clearance details

Applicant: Wilson-Cook Medical, Inc.
Product code: Code QAU
Advisory panel: General, Plastic Surgery
Date received: 2017-03-09
Decision date: 2018-05-07
Decision: Unknown
Clearance type: Direct
Location: Winston-Salem, NC, US

View on FDA.gov ↗

Adverse events under product code QAU

product code QAU

Death: 6
Injury: 135
Malfunction: 621
Total: 762

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.