SORBASTACE— 510(k) K965034

Name: FDA 510(k) clearance K965034
Creator: U.S. Food and Drug Administration
Published: 1998-04-09

Substantially Equivalent for Some Indications

Hemostace, LLC

FDA 510(k) clearance K965034 for SORBASTACE, Substantially Equivalent for Some Indications on 1998-04-09. Applicant: Hemostace, LLC. Device class: Unclassified.

Clearance details

Applicant: Hemostace, LLC
Product code: Code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 1996-12-17
Decision date: 1998-04-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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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.