DeviceClearance

K001184

Substantially Equivalent for Some Indications

SILK, NONABSORBABLE, SURGICAL SUTURES, USP

Applicant
Cp Medical
Product code
GAP
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
Portland, OR, 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.