FDA 510(k)

Hilzo Esophageal Stents

Número K: K223266 · 2024-01-16

Data da decisão2024-01-16

Código do produtoESW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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Fonte oficial

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