Exofin Fusion Skin Closure System— 510(k) K171442

Substantially Equivalent

Chemence Medical, Inc.

FDA 510(k) clearance K171442 for Exofin Fusion Skin Closure System, Substantially Equivalent on 2017-09-25. Applicant: Chemence Medical, Inc..

Clearance details

Applicant: Chemence Medical, Inc.
Product code: Code OMD
Advisory panel: General, Plastic Surgery
Date received: 2017-05-16
Decision date: 2017-09-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OMD

product code OMD

Injury: 1,134
Total: 1,134

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.