FDA 510(k)

Esophageal TTS Stent

Numéro K : K240522 · 2024-03-22

Date de décision2024-03-22

Code produitESW

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (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.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific K233837Agile Esophageal Stent SystemBoston Scientific Corporation

Source officielle

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