K930739

Substantially Equivalent

SUTURES POLYPROP., POLYETHELINE, NYLON & SILK

Applicant
Deknatel, Inc.
Product code
GAP
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Jose-Heredia, CR
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.