WoundClot9— 510(k) K160679

Substantially Equivalent

Core Scientific Creation , Ltd.

FDA 510(k) clearance K160679 for WoundClot9, Substantially Equivalent on 2016-08-08. Applicant: Core Scientific Creation , Ltd..

Clearance details

Applicant: Core Scientific Creation , Ltd.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2016-03-10
Decision date: 2016-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

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.