DeviceClearance

K050845

Substantially Equivalent

MONOCRYL PLUS ANTIBACTERIAL SUTURE

Applicant
ETHICON, Inc.
Product code
GAM
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 GAM

product code GAM
Death
45
Injury
5,711
Malfunction
30,744
Other
4
Total
36,504

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.