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FDA 510(k)

Hilzo Esophageal Stents

K-Number: K223266 · 2024-01-16

ApplicantThoracent, Inc.
Decision Date2024-01-16
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Hilzo Esophageal Stents?

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

When was Hilzo Esophageal Stents approved by the FDA?

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

What company makes Hilzo Esophageal Stents?

Hilzo Esophageal Stents is manufactured by Thoracent, Inc..

What is the FDA product code for Hilzo Esophageal Stents?

The FDA product code for Hilzo Esophageal Stents is ESW.

Related Devices (Code: ESW)

K162717Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd. K180144Agile Esophageal Stent SystemBoston Scientific Corporation K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K182910Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd. K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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