FDA.report

510(k) K223266

Device
Hilzo Esophageal Stents
Applicant
Thoracent, Inc.
510(k) number
K223266
Product code
ESW
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-16
Date received
2022-10-24
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
Brian Lynch
Address
120 New York Ave. Unit 6w Huntington NY US 11743 11743

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
K233837Agile Esophageal Stent SystemBoston Scientific Corporation2024-04-04
K240522Esophageal TTS StentTaewoong Medical2024-03-22
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