K020146

Substantially Equivalent

SERRALNYL

Applicant
Serral, S.A. DE C.V.
Product code
GAR
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Williamsburg, VA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GAR

product code GAR
Injury
422
Malfunction
3,386
Other
4
Total
3,812

Source: openFDA MAUDE database, through . 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.