SOFTSEAL-C— 510(k) K112864

Substantially Equivalent

Chitogen, Inc.

FDA 510(k) clearance K112864 for SOFTSEAL-C, Substantially Equivalent on 2012-08-02. Applicant: Chitogen, Inc..

Clearance details

Applicant: Chitogen, Inc.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2011-09-30
Decision date: 2012-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.