HEMO-Bandage— 510(k) K151204

Name: FDA 510(k) clearance K151204
Creator: U.S. Food and Drug Administration
Published: 2015-07-31

Substantially Equivalent

Coreleader Biotech Co., Ltd.

FDA 510(k) clearance K151204 for HEMO-Bandage, Substantially Equivalent on 2015-07-31. Applicant: Coreleader Biotech Co., Ltd.. Device class: Unclassified.

Clearance details

Applicant: Coreleader Biotech Co., Ltd.
Product code: Code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2015-05-05
Decision date: 2015-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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K111578 — CORELEADER COLLA-ALGI FIBER MODEL CAW2011-09-23
K111733 — CORELEADER SCAR-DIMMER2011-09-22
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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.