510(k) K240389— Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)

Substantially Equivalent

Hyundae Meditech Co., Ltd.

Clearance details

Applicant: Hyundae Meditech Co., Ltd.
Product code: Code NEW
Advisory panel: General, Plastic Surgery
Date received: 2024-02-08
Decision date: 2024-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wonju-Si, KR

Adverse events under product code NEW

product code NEW

Death: 32
Injury: 2,179
Malfunction: 8,975
Total: 11,186

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.