510(k) K060046— DERMASTREAM

Substantially Equivalent

Enzysurge , Ltd.

Clearance details

Applicant: Enzysurge , Ltd.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 2006-01-06
Decision date: 2006-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, MA, US

Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

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.