NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING— 510(k) K122886

Substantially Equivalent

Hemostasis, LLC

FDA 510(k) clearance K122886 for NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING, Substantially Equivalent on 2012-11-15. Applicant: Hemostasis, LLC.

Clearance details

Applicant: Hemostasis, LLC
Product code: Code QSY
Advisory panel: Unknown
Date received: 2012-09-20
Decision date: 2012-11-15
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

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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.