FDA.report

510(k) K233837

Device
Agile Esophageal Stent System
Applicant
Boston Scientific Corporation
510(k) number
K233837
Product code
ESW
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-04
Date received
2023-12-04
Regulation
878.3610
Classification name
Prosthesis, Esophageal
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Alexis Erazo
Address
100 Boston Scientific Way Marlboro MA US 01752 01752

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code ESW

510(k)DeviceApplicantDecision date
K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.2025-10-30
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
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