DeviceClearance

K001625

Substantially Equivalent

PRONOVA NONABSORBABLE SUTURE, USP

Applicant
ETHICON, Inc.
Product code
GAW
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Somerville, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GAW

product code GAW
Death
66
Injury
1,616
Malfunction
10,428
Total
12,110

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.