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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 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.

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. 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.

Related Devices (Code: ESW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific CorporationK253327HANAROSTENT 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 ScientificK233837Agile Esophageal 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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