FDA 510(k)

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System

K-Number: K233939 · 2024-04-29

Decision Date2024-04-29

Product CodeESW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2024-04-29 under 510(k) number K233939. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System?

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System is a medical device that received FDA 510(k) clearance on 2024-04-29. The listed applicant is Boston Scientific. The 510(k) number is K233939.

When did Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System receive FDA 510(k) clearance?

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System received FDA 510(k) clearance on 2024-04-29, under 510(k) number K233939.

Who is the listed applicant for Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System?

The FDA 510(k) record lists Boston Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System?

The FDA product code for Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System is ESW.

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Related Devices (Code: ESW)

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.K233837Agile Esophageal Stent SystemBoston Scientific Corporation K240522Esophageal TTS StentTaewoong Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.