HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)— 510(k) K180180
Substantially EquivalentM.I.Tech Co., Ltd.
FDA 510(k) clearance K180180 for HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN), Substantially Equivalent on 2018-11-02. Applicant: M.I.Tech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- M.I.Tech Co., Ltd.
- Product code
- Code MQR
- Device class
- Class 2
- Regulation
- 21 CFR 878.3610
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pyeongtaek-Si, KR
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More clearances from M.I.Tech Co., Ltd.
view allAdverse events under product code MQR
product code MQR- Death
- 11
- Injury
- 149
- Total
- 160
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.