CHITOGAUZE FUSION— 510(k) K111163

Substantially Equivalent

Hem Con Medical Technologies, Inc.

FDA 510(k) clearance K111163 for CHITOGAUZE FUSION, Substantially Equivalent on 2011-05-17. Applicant: Hem Con Medical Technologies, Inc..

Clearance details

Applicant: Hem Con Medical Technologies, Inc.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2011-04-26
Decision date: 2011-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Portland, OR, US

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.