FDA.reportPublic FDA data

510(k) K253327

Device
HANAROSTENT Esophagus Upper (CCC)
Applicant
M.I.Tech Co., Ltd.
510(k) number
K253327
Product code
ESW
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-30
Date received
2025-09-30
Regulation
878.3610
Classification name
Prosthesis, Esophageal
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jeongeun Park
Address
174 Habuk 2-Gil, Jinwi-Myeon, Pyeongtaek-Si, Gyeonggi-Do KR 17706 17706

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ESW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.2025-10-30
K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.2025-07-23
K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024-04-29
K233837Agile Esophageal Stent SystemBoston Scientific Corporation2024-04-04
K240522Esophageal TTS StentTaewoong Medical2024-03-22
K223266Hilzo Esophageal StentsThoracent, Inc.2024-01-16
K221482Esophageal TTS StentTaewoong Medical Co., Ltd.2022-06-22
K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation2021-11-22
K213251HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd.2021-11-18
K211706Esophageal TTS StentTaewoong Medical Co., Ltd.2021-10-08
K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd.2021-07-23
K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd.2020-05-20
K182910Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.2019-05-29
K180144Agile Esophageal Stent SystemBoston Scientific Corporation2018-09-21
K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.2018-05-18