WOUNDCLOT HEMOSTATIC GAUZE— 510(k) K140573

Substantially Equivalent

Core Scientific , Ltd.

FDA 510(k) clearance K140573 for WOUNDCLOT HEMOSTATIC GAUZE, Substantially Equivalent on 2014-11-24. Applicant: Core Scientific , Ltd..

Clearance details

Applicant: Core Scientific , Ltd.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2014-03-06
Decision date: 2014-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shave-Zion, IL

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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.