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ESW — Prosthesis, Esophageal Class II

FDA Device Classification

Classification Details

Product Code
ESW
Device Class
Class II
Regulation Number
878.3610
Submission Type
Review Panel
GU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243619taewoong medical coNiti-S Esophageal Stent; Esophageal TTS StentOctober 30, 2025
K253327m.i. tech coHANAROSTENT Esophagus Upper (CCC)October 30, 2025
K251265merit medical systemsResilience Fully Covered Esophageal Stent SystemJuly 23, 2025
K233939boston scientificUltraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemApril 29, 2024
K233837boston scientific corporationAgile Esophageal Stent SystemApril 4, 2024
K240522taewoong medicalEsophageal TTS StentMarch 22, 2024
K223266thoracentHilzo Esophageal StentsJanuary 16, 2024
K221482taewoong medical coEsophageal TTS StentJune 22, 2022
K211960boston scientific corporationAgile Esophageal OTW Stent SystemNovember 22, 2021
K213251m.i. tech coHANAROSTENT Esophagus Asymmetric (CCC)November 18, 2021
K211706taewoong medical coEsophageal TTS StentOctober 8, 2021
K201160m.i. tech coHANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)July 23, 2021
K200860m.i. tech coHANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)May 20, 2020
K182910micro-tech (nanjing) coSegmented Esophageal Stent SystemMay 29, 2019
K180144boston scientific corporationAgile Esophageal Stent SystemSeptember 21, 2018
K172813micro-tech (nanjing) coEsophageal Stent SystemMay 18, 2018
K162717cook irelandEvolution Esophageal Stent System – Partially CoveredDecember 21, 2016
K130004boston scientific corporationULTRAFLEX ESOPHAGEAL NG STENT SYSTEMDecember 6, 2013
K123205taewoong medical coESOPHAGEAL TTS STENTOctober 9, 2013
K120983boston scientific corporationULTRAFLEX ESOPHAGEAL NG STENT SYSTEMMay 2, 2012