EndoClot— 510(k) K190677

Substantially Equivalent

Endoclot Plus Co., Ltd.

FDA 510(k) clearance K190677 for EndoClot, Substantially Equivalent on 2021-01-29. Applicant: Endoclot Plus Co., Ltd..

Clearance details

Applicant: Endoclot Plus Co., Ltd.
Product code: Code QAU
Advisory panel: General, Plastic Surgery
Date received: 2019-03-15
Decision date: 2021-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code QAU

product code QAU

Death: 6
Injury: 135
Malfunction: 621
Total: 762

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.