FDA 510(k)

Hilzo Esophageal Stents

K-Nummer: K223266 · 2024-01-16

Entscheidungsdatum2024-01-16

ProduktcodeESW

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Hilzo Esophageal Stents is the device name listed in this FDA 510(k) record. The listed applicant is Thoracent, Inc.. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K223266. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Hilzo Esophageal Stents?

Hilzo Esophageal Stents is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Thoracent, Inc.. The 510(k) number is K223266.

When did Hilzo Esophageal Stents receive FDA 510(k) clearance?

Hilzo Esophageal Stents received FDA 510(k) clearance on 2024-01-16, under 510(k) number K223266.

Who is the listed applicant for Hilzo Esophageal Stents?

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

What is the FDA product code for Hilzo Esophageal Stents?

The FDA product code for Hilzo Esophageal Stents is ESW.

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Verwandte Geräte (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 Ösophageal Stent-SystemBoston Scientific Corporation

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