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FDA 510(k)

Esophageal TTS Stent

K-Number: K240522 · 2024-03-22

ApplicantTaewoong Medical
Decision Date2024-03-22
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Esophageal TTS Stent is a medical device manufactured by Taewoong Medical. It received FDA 510(k) clearance on 2024-03-22 under approval number K240522. 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 Esophageal TTS Stent?

Esophageal TTS Stent is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Taewoong Medical. The 510(k) number is K240522.

When was Esophageal TTS Stent approved by the FDA?

Esophageal TTS Stent received FDA 510(k) clearance on 2024-03-22, under approval number K240522.

What company makes Esophageal TTS Stent?

Esophageal TTS Stent is manufactured by Taewoong Medical.

What is the FDA product code for Esophageal TTS Stent?

The FDA product code for Esophageal TTS Stent 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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