K913185

Substantially Equivalent

STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT

Applicant
Internacional Farmaceutica, S.A. DE C.V.
Product code
GAQ
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Great Neck, NY, US
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.