CELOX RAPID GAUZE— 510(k) K110386

Substantially Equivalent

Medtrade Products , Ltd.

FDA 510(k) clearance K110386 for CELOX RAPID GAUZE, Substantially Equivalent on 2011-05-10. Applicant: Medtrade Products , Ltd..

Clearance details

Applicant: Medtrade Products , Ltd.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2011-02-10
Decision date: 2011-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crewe, GB

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.