HANAROSTENT Esophagus Upper (CCC)
FDA 510(k) K253327 · M.I.Tech Co., Ltd.
510(k) numberK253327
Submission
- Device name
- HANAROSTENT Esophagus Upper (CCC)
- Applicant
- M.I.Tech Co., Ltd.
Pyeongtaek-Si, Gyeonggi-Do, KR - Received
- September 30, 2025
- Decision date
- October 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ESW – Prosthesis, Esophageal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3610
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code ESW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | Boston Scientific Corporation | 07/10/2026SE |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS StentESW · Traditional | Taewoong Medical Co., Ltd. | 10/30/2025SE |
| K251265 | Resilience Fully Covered Esophageal Stent SystemESW · Traditional | Merit Medical Systems, Inc. | 07/23/2025SE |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemESW · Traditional | Boston Scientific | 04/29/2024SE |
| K233837 | Agile Esophageal Stent SystemESW · Traditional | Boston Scientific Corporation | 04/04/2024SE |
| K240522 | Esophageal TTS StentESW · Special | Taewoong Medical | 03/22/2024SE |
| K223266 | Hilzo Esophageal StentsESW · Traditional | Thoracent, Inc. | 01/16/2024SE |
| K221482 | Esophageal TTS StentESW · Special | Taewoong Medical Co., Ltd. | 06/22/2022SE |
| K211960 | Agile Esophageal OTW Stent SystemESW · Traditional | Boston Scientific Corporation | 11/22/2021SE |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC)ESW · Special | M.I.Tech Co., Ltd. | 11/18/2021SE |
More from M.I.Tech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC)ESW · Special | 11/18/2021SE |
| K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)ESW · Traditional | 07/23/2021SE |
| K202973 | HANAROSTENT Benefit Biliary (NNN)FGE · Traditional | 05/11/2021SESU |
| K201342 | HANAROSTENT Trachea/Bronchium (CCC)JCT · Traditional | 12/31/2020SE |
| K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)ESW · Traditional | 05/20/2020SE |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN)MQR · Special | 03/07/2019SE |
| K183396 | HANAROSTENT FASTTM Biliary (NNN)FGE · Traditional | 02/11/2019SESU |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)MQR · Traditional | 01/10/2019SE |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)MQR · Traditional | 11/02/2018SE |
| K160893 | HANAROCare ReJuNUH · Traditional | 07/27/2016SE |
Questions and answers
When was HANAROSTENT Esophagus Upper (CCC) cleared by the FDA?
HANAROSTENT Esophagus Upper (CCC) (K253327) received a 510(k) decision of Substantially Equivalent on October 30, 2025, 30 days after the submission was received.
What is the product code of K253327?
The FDA product code is ESW – Prosthesis, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 878.3610.