DeviceClearance

K030782

Substantially Equivalent

SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

Applicant
W. L. Gore & Associates, Inc.
Product code
FTM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Flagstaff, AZ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FTM

product code FTM
Death
17
Injury
2,174
Total
2,191

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.