K102459

Substantially Equivalent

NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE

Applicant: Hemostasis, LLC
Product code: QSY
Advisory panel: Unknown
Date received: 2010-08-27
Decision date: 2010-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.