DeviceClearance

K241486

Substantially Equivalent

Sofsilk™ Coated Braided Silk Suture

Applicant
Covidien
Product code
GAP
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Haven, CT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GAP

product code GAP
Death
3
Injury
491
Malfunction
2,253
Total
2,747

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.