DeviceClearance

K964072

Substantially Equivalent

MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED

Applicant
ETHICON, Inc.
Product code
GAN
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 GAN

product code GAN
Injury
599
Malfunction
1,658
Total
2,257

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.