K200767

Substantially Equivalent

SilverStream Gel

Applicant: Enzysurge , Ltd.
Product code: FRO
Advisory panel: Unknown
Date received: 2020-03-25
Decision date: 2020-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosh Ha'Ayin, IL

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.