K180180

Substantially Equivalent

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)

Applicant: M.I.Tech Co., Ltd.
Product code: MQR
Advisory panel: General, Plastic Surgery
Date received: 2018-01-23
Decision date: 2018-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyeongtaek-Si, KR

Adverse events under product code MQR

product code MQR

Death: 11
Injury: 149
Total: 160

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.