STATSEAL DISC— 510(k) K130324

Substantially Equivalent

Biolife, LLC

FDA 510(k) clearance K130324 for STATSEAL DISC, Substantially Equivalent on 2013-07-09. Applicant: Biolife, LLC.

Clearance details

Applicant: Biolife, LLC
Product code: Code QSY
Advisory panel: Unknown
Date received: 2013-02-08
Decision date: 2013-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, 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.