DeviceClearance

K240389

Substantially Equivalent

Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)

Applicant
Hyundae Meditech Co., Ltd.
Product code
NEW
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wonju-Si, KR
Download summary PDF View on FDA.gov ↗

Adverse events under product code NEW

product code NEW
Death
32
Injury
2,179
Malfunction
8,975
Total
11,186

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.