derma+flex QS High Viscosity Tissue Adhesive— 510(k) K162352

Substantially Equivalent

Chemence Medical, Inc.

FDA 510(k) clearance K162352 for derma+flex QS High Viscosity Tissue Adhesive, Substantially Equivalent on 2016-12-22. Applicant: Chemence Medical, Inc..

Clearance details

Applicant: Chemence Medical, Inc.
Product code: Code MPN
Advisory panel: General, Plastic Surgery
Date received: 2016-08-23
Decision date: 2016-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MPN

product code MPN

Injury: 856
Other: 1
Total: 857

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.