FDA 510(k)

Esophageal TTS Stent

Número K: K221482 · 2022-06-22

Data da decisão2022-06-22

Código do produtoESW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Esophageal TTS Stent is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-06-22 under 510(k) number K221482. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Esophageal TTS Stent?

Esophageal TTS Stent is a medical device that received FDA 510(k) clearance on 2022-06-22. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K221482.

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

Esophageal TTS Stent received FDA 510(k) clearance on 2022-06-22, under 510(k) number K221482.

Who is the listed applicant for Esophageal TTS Stent?

The FDA 510(k) record lists Taewoong Medical Co., Ltd. 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.

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Outros registros que listam Taewoong Medical Co., Ltd. como candidato(a)

K260962Sphincterotome K252648Niti-S SPAXUS Stent K251123Niti-S Biliary Stent; Niti-S Biliary Slim M Stent K243619Niti-S Esophageal Stent; Esophageal TTS Stent K250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: 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 K233837Sistema de Stent de Esôfago da AgileBoston Scientific Corporation

Fonte oficial

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