HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)— 510(k) K200860
Substantially EquivalentM.I.Tech Co., Ltd.
FDA 510(k) clearance K200860 for HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN), Substantially Equivalent on 2020-05-20. 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
- Traditional
- Location
- Pyeongtaek-Si, 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
- K253327 — HANAROSTENT Esophagus Upper (CCC)
- K251265 — Resilience Fully Covered Esophageal Stent System
- K233939 — Ultraflex Esophageal NG Stent System; WallFlex 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.