DeviceClearance

K220880

Substantially Equivalent

Arthrex BioSuture

Applicant
Arthrex, Inc.
Product code
GAT
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Naples, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GAT

product code GAT
Death
19
Injury
4,163
Malfunction
8,646
Other
2
Total
12,830

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.