FDA 510(k)

Esophageal TTS Stent

Номер K: K240522 · 2024-03-22

Дата решения2024-03-22

Код продуктаESW

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Esophageal TTS Stent is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K240522. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Esophageal TTS Stent?

Esophageal TTS Stent is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Taewoong Medical. The 510(k) number is K240522.

When did Esophageal TTS Stent receive FDA 510(k) clearance?

Esophageal TTS Stent received FDA 510(k) clearance on 2024-03-22, under 510(k) number K240522.

Who is the listed applicant for Esophageal TTS Stent?

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

What is the FDA product code for Esophageal TTS Stent?

The FDA product code for Esophageal TTS Stent is ESW.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific K233837Agile Esophageal Stent SystemBoston Scientific Corporation

Официальный источник

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