HANAROSTENT Esophagus Upper (CCC)— 510(k) K253327
Substantially EquivalentM.I.Tech Co., Ltd.
FDA 510(k) clearance K253327 for HANAROSTENT Esophagus Upper (CCC), Substantially Equivalent on 2025-10-30. Applicant: M.I.Tech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- M.I.Tech Co., Ltd.
- Product code
- Code ESW
- Device class
- Class 2
- Regulation
- 21 CFR 878.3610
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pyeongtaek-Si, Gyeonggi-Do, KR
Recent devices under product code ESW
view all- K261978 — WallFlex Esophageal Stent System; Agile Esophageal Over-the-Wire (OTW) Stent System
- K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent
- K251265 — Resilience Fully Covered Esophageal Stent System
- K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
- K233837 — Agile Esophageal Stent System
More clearances from M.I.Tech Co., Ltd.
view allAdverse events under product code ESW
product code ESW- Death
- 11
- Injury
- 353
- Malfunction
- 442
- Total
- 806
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.