HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)— 510(k) K183616

Substantially Equivalent

M.I.Tech Co., Ltd.

FDA 510(k) clearance K183616 for HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN), Substantially Equivalent on 2019-01-10. Applicant: M.I.Tech Co., Ltd..

Clearance details

Applicant: M.I.Tech Co., Ltd.
Product code: Code MQR
Advisory panel: General, Plastic Surgery
Date received: 2018-12-26
Decision date: 2019-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyeongtaek-Si, KR

Download summary PDF View on FDA.gov ↗

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.