K865038

Substantially Equivalent

SURGISTEEL

Applicant
Sutures , Ltd.
Product code
GAQ
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ruabon, Wrexham, GB
Download summary PDF View on FDA.gov ↗

Adverse events under product code GAQ

product code GAQ
Death
3
Malfunction
522
Total
525

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.